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Trial record 1 of 1 for:    NCT02202434
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Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202434
Recruitment Status : Recruiting
First Posted : July 29, 2014
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Stenosis
Interventions Device: Lotus Valve System
Device: CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
Device: LOTUS Edge Valve System
Enrollment 1475
Recruitment Details

912 subjects randomized from 22Sep2014 to 24Dec2015. 102 subjects enrolled in the Roll-in cohort. 295 subjects enrolled in the US CAS from 25Feb2016 to 23Feb2017. Enrollment in the LOTUS Edge Valve System – Single-arm Edge Nested Reg is ongoing.

Enrollment in the LOTUS Edge Valve System – Single-arm 29mm Reg and Roll-in Cohorts has not begun.

Pre-assignment Details

The non-randomized Roll-In phase with only the test device was for centers with no previous experience implanting the Lotus Valve System. Each performed at least two Roll-In cases before starting RCT.

Only cohorts that have completed enrollment, reached primary endpoint and were submitted for regulatory approval are included in the Results Section

Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Period Title: Overall Study
Started 607 305 102 295
Completed 498 236 87 258
Not Completed 109 69 15 37
Reason Not Completed
Death             70             39             13             27
Lost to Follow-up             1             1             1             0
Physician Decision             2             3             0             0
Withdrawal by Subject             13             14             1             4
Completed Study             1             0             0             0
Visit Missed             21             12             0             5
Other             1             0             0             1
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort Total
Hide Arm/Group Description

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Total of all reporting groups
Overall Number of Baseline Participants 607 305 102 295 1309
Hide Baseline Analysis Population Description
Data are reported separately for each cohort as pooled mean and standard deviations across cohorts do not provide meaningful data.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
Lotus Valve System - Randomized 82.8  (7.1) 0  (0) 0  (0) 0  (0) 82.8  (7.1)
CoreValve TAVR System - Randomize 0  (0) 82.9  (7.6) 0  (0) 0  (0) 82.9  (7.6)
Lotus Valve System - Single-arm Roll-in Cohort 0  (0) 0  (0) 83.6  (6.9) 0  (0) 83.6  (6.9)
Lotus Valve System - Single-arm Continued Access 0  (0) 0  (0) 0  (0) 81.7  (6.6) 81.7  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
Female
304
  50.1%
159
  52.1%
52
  51.0%
137
  46.4%
652
  49.8%
Male
303
  49.9%
146
  47.9%
50
  49.0%
158
  53.6%
657
  50.2%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
American Indian or Alaska Native
1
   0.2%
0
   0.0%
1
   1.0%
1
   0.3%
3
   0.2%
Asian
3
   0.5%
2
   0.7%
0
   0.0%
4
   1.4%
9
   0.7%
Black, of African Heritage
17
   2.8%
11
   3.6%
4
   3.9%
13
   4.4%
45
   3.4%
Caucasian
537
  88.5%
271
  88.9%
93
  91.2%
271
  91.9%
1172
  89.5%
Hispanic or Latino
18
   3.0%
2
   0.7%
4
   3.9%
6
   2.0%
30
   2.3%
Native Hawaiian or other Pacific Islander
2
   0.3%
1
   0.3%
0
   0.0%
0
   0.0%
3
   0.2%
Other
3
   0.5%
4
   1.3%
0
   0.0%
1
   0.3%
8
   0.6%
Unknown or Not Reported
28
   4.6%
14
   4.6%
1
   1.0%
0
   0.0%
43
   3.3%
[1]
Measure Description: Subjects were allowed to select more than one option.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
Canada 1 1 2 0 4
Netherlands 4 2 0 0 6
United States 531 261 100 295 1187
Australia 15 8 0 0 23
France 23 13 0 0 36
Germany 33 20 0 0 53
Society of Thoracic Surgeons (STS) Risk Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
Lotus Valve System - Randomized 6.7  (4.0) 0  (0) 0  (0) 0  (0) 6.7  (4.0)
CoreValve TAVR System - Randomized 0  (0) 6.9  (4.1) 0  (0) 0  (0) 6.9  (4.1)
Lotus Valve System - Single-arm Roll-in Cohort 0  (0) 0  (0) 7.0  (4.9) 0  (0) 7.0  (4.9)
Lotus Valve System - Single-arm Continued Access 0  (0) 0  (0) 0  (0) 5.4  (2.9) 5.4  (2.9)
[1]
Measure Description: The Society of Thoracic Surgeons Score is a risk model used to predict a subject’s risk of mortality and morbidities for the most commonly performed cardiac surgeries. The model is a percentage score from 0 to 100 where a lower score means a lower risk and higher score means a higher risk.
European System for Cardiac Operative Risk Evaluation (EuroSCORE)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
Lotus Valve System - Randomized 6.4  (5.5) 0  (0) 0  (0) 0  (0) 6.4  (5.5)
CoreValve TAVR System - Randomized 0  (0) 6.4  (5.5) 0  (0) 0  (0) 6.4  (5.5)
Lotus Valve System - Single-arm Roll-in Cohort 0  (0) 0  (0) 6.4  (6.5) 0  (0) 6.4  (6.5)
Lotus Valve System - Single-arm Continued Access 0  (0) 0  (0) 0  (0) 5.3  (5.9) 5.3  (5.9)
[1]
Measure Description: The European System for Cardiac Operative Risk Evaluation is a risk model where if a risk factor is present in a subject, a weight or number is assigned. The weights are added to give an approximate percent predicted mortality. A higher score means a higher risk and a lower score means a lower risk.
New York Heart Association (NYHA) Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 607 participants 305 participants 102 participants 295 participants 1309 participants
NYHA I 0 0 0 0 0
NYHA II 174 98 22 108 402
NYHA III 386 186 70 171 813
NYHA IV 47 21 10 16 94
[1]
Measure Description: New York Heart Association Classification is a system for defining cardiac disease and related functional limitations into four broad categorizations. The categories range from NYHA I (No limitations) to NYHA IV (inability to carry out any physical activity without discomfort).
1.Primary Outcome
Title Percentage of Participants With Events Included in the Primary Safety Endpoint
Hide Description Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
Time Frame 30 days following procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 577 297
Measure Type: Number
Unit of Measure: Percent of participants
20.3 17.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lotus Valve System - Randomized, CoreValve TAVR System - Randomized
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 10.5% non-inferiority margin
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Farrington-Manning
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 3.1
Confidence Interval (1-Sided) 97.5%
8.32
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Events Included in the Primary Effectiveness Endpoint
Hide Description Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).
Time Frame 1 year following procedure
Hide Outcome Measure Data
Hide Analysis Population Description

Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.

Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms.

Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305
Measure Type: Number
Unit of Measure: Percent of Participants
Implanted Number Analyzed 577 participants 297 participants
15.4 25.5
Intent to Treat Number Analyzed 607 participants 305 participants
15.8 26.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lotus Valve System - Randomized, CoreValve TAVR System - Randomized
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 9.5% Non-Inferiority margin
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Farrington-Manning
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -10.1
Confidence Interval (1-Sided) 97.5%
-4.41
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lotus Valve System - Randomized, CoreValve TAVR System - Randomized
Comments

Superiority analysis was only to be run if the non-inferiority analysis was met.

Superiority analysis was run on Intent to Treat Population.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-16.3 to -4.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation
Hide Description Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).
Time Frame 1 year following procedure
Hide Outcome Measure Data
Hide Analysis Population Description

ITT - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted.

The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.

Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305
Measure Type: Number
Unit of Measure: Percent of Participants
0.9 6.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lotus Valve System - Randomized, CoreValve TAVR System - Randomized
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -6.1
Confidence Interval (2-Sided) 95%
-9.6 to -2.6
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Percentage of Participants With Successful Deployment of the Study Valve
Hide Description Successful deployment of the study valve
Time Frame at discharge or 7 days post-procedure (whichever comes first)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
97.8 99.0 99.0 96.6
5.Other Pre-specified Outcome
Title Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted
Hide Description Successful retrieval of the study valve if retrieval is attempted
Time Frame at discharge or 7 days post-procedure (whichever comes first)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intent to Treat participants who had Retrieval attempted
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 40 14 5 24
Measure Type: Number
Unit of Measure: Percentage of Participants
100 92.9 100 100
6.Other Pre-specified Outcome
Title Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted
Hide Description Successful repositioning of the study valve if repositioning is attempted
Time Frame at discharge or 7 days post-procedure (whichever comes first)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Intent to Treat participants who had Repositioning attempted
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 197 35 46 140
Measure Type: Number
Unit of Measure: Percentage of Participants
100 100 100 97.1
7.Other Pre-specified Outcome
Title Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Hide Description

Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.

The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).

Time Frame at discharge or 7 days post-procedure (whichever comes first)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of Participants
Central - Trace or Greater 15.2 8.7 15.8 15.3
Central - None 84.8 91.3 84.2 84.7
Central - Trace/Trivial 6.1 1.8 6.3 4.0
Central - Mild 4.2 0.7 3.2 4.7
Central - Mild-Moderate 0.0 0.0 0.0 0.0
Central - Moderate 0.0 0.4 1.1 0.0
Central - Moderate-Severe 0.0 0.0 0.0 0.0
Central - Severe 0.0 0.0 0.0 0.0
Central - Moderate or Greater 0.0 0.4 1.1 0.0
Central - AR but Severity Not Evaluable 4.9 5.8 5.3 6.6
Paravalvular - Trace or Greater 26.9 72.6 28.4 28.5
Paravalvular - None 73.1 27.4 71.6 71.5
Paravalvular - Trace/Trivial 10.5 18.1 12.6 2.9
Paravalvular - Mild 11.8 46.9 12.6 18.2
Paravalvular - Mild-Moderate 0.0 0.0 0.0 0.0
Paravalvular - Moderate 0.4 3.6 0.0 0.4
Paravalvular - Moderate-Severe 0.0 0.0 0.0 0.0
Paravalvular - Severe 0.0 0.0 0.0 0.0
Paravalvular - Moderate or Greater 0.4 3.6 0.0 0.4
Paravalvular - AR but Severity Not Evaluable 4.3 4.0 3.2 6.9
Total – Trace or Greater 35.1 73.3 36.8 34.7
Total - None 64.9 26.7 63.2 65.3
Total - Trace/Trivial 17.4 18.4 20.0 8.8
Total - Mild 15.4 48.7 15.8 24.5
Total - Mild-Moderate 0.0 0.0 0.0 0.0
Total - Moderate 0.9 4.3 1.1 0.4
Total - Moderate-Severe 0.0 0.0 0.0 0.0
Total - Severe 0.0 0.0 0.0 0.0
Total - Moderate or Greater 0.9 4.3 1.1 0.4
Total - AR but Severity Not Evaluable 1.4 1.8 0.0 1.1
8.Other Pre-specified Outcome
Title Percentage of Participants With Clinical Procedural Success
Hide Description Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding
Time Frame 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of Participants
81.4 84.6 81.4 81.0
9.Other Pre-specified Outcome
Title Percentage of Participants With Procedural Success
Hide Description Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for body surface area (BSA) <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events
Time Frame 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
32.0 39.2 33.3 29.3
10.Other Pre-specified Outcome
Title Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
Hide Description Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Mean (Standard Deviation)
Unit of Measure: cm^2
Discharge or 7 Days - Aortic Valve Area 1.65  (0.47) 1.96  (0.52) 1.70  (0.49) 1.61  (0.42)
30 Days - Aortic Valve Area 1.59  (0.45) 1.98  (0.51) 1.62  (0.46) 1.55  (0.41)
6 Months - Aortic Valve Area 1.46  (0.46) 1.74  (0.55) 1.55  (0.45) 1.56  (0.47)
1 Year - Aortic Valve Area 1.49  (0.45) 1.69  (0.52) 1.53  (0.49) 1.51  (0.46)
11.Other Pre-specified Outcome
Title Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
Hide Description Assessed by an independent core laboratory - mean and peak aortic gradients
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Hide Outcome Measure Data
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Mean (Standard Deviation)
Unit of Measure: mmHg
Discharge or 7 Days - Mean Aortic Valve Gradient 12.20  (5.21) 8.19  (3.98) 12.13  (5.13) 12.50  (6.01)
Discharge or 7 Days - Peak Aortic Gradient 22.28  (10.23) 15.21  (7.20) 21.58  (8.55) 22.89  (10.91)
30 Days - Mean Aortic Valve Gradient 12.00  (6.08) 7.25  (3.44) 12.76  (8.24) 12.24  (6.73)
30 Days - Peak Aortic Gradient 21.46  (10.27) 13.59  (6.21) 23.02  (13.43) 22.56  (11.44)
6 Months - Mean Aortic Valve Gradient 11.93  (5.21) 7.89  (4.24) 12.33  (5.89) 12.20  (5.42)
6 Months - Peak Aortic Gradient 22.24  (9.82) 14.84  (7.46) 22.85  (10.60) 22.68  (9.81)
1 Year - Mean Aortic Valve Gradient 12.29  (5.83) 7.89  (3.48) 12.30  (7.39) 12.68  (5.62)
1 Year - Peak Aortic Gradient 22.74  (10.53) 15.22  (6.44) 22.03  (12.05) 23.75  (9.83)
12.Other Pre-specified Outcome
Title Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
Hide Description Assessed by an independent core laboratory - peak aortic velocity
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Mean (Standard Deviation)
Unit of Measure: m/s
Discharge or 7 Days - Peak Aortic Velocity 2.30  (0.48) 1.89  (0.45) 2.28  (0.44) 2.33  (0.53)
30 Days - Peak Aortic Velocity 2.26  (0.46) 1.80  (0.40) 2.33  (0.58) 2.31  (0.53)
6 Months - Peak Aortic Velocity 2.30  (0.46) 1.87  (0.44) 2.32  (0.49) 2.33  (0.49)
1 Year - Peak Aortic Velocity 2.33  (0.51) 1.91  (0.41) 2.28  (0.55) 2.39  (0.47)
13.Other Pre-specified Outcome
Title Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Hide Description

Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.

The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).

Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge Paravalvular – Trace or Greater 26.9 72.6 28.4 28.5
Discharge Paravalvular None 73.1 27.4 71.6 71.5
Discharge Paravalvular Trace/Trivial 10.5 18.1 12.6 2.9
Discharge Paravalvular Mild 11.8 46.9 12.6 18.2
Discharge Paravalvular Mild-Moderate 0.0 0.0 0.0 0.0
Discharge Paravalvular Moderate 0.4 3.6 0.0 0.4
Discharge Paravalvular Moderate-Severe 0.0 0.0 0.0 0.0
Discharge Paravalvular Severe 0.0 0.0 0.0 0.0
Discharge Paravalvular Moderate or Greater 0.4 3.6 0.0 0.4
Discharge ParavalvularAR but Severity not evaluabl 4.3 4.0 3.2 6.9
30 Day Paravalvular – Trace or Greater 27.5 75.5 30.0 27.3
30 Day Paravalvular None 72.5 24.5 70.0 72.7
30 Day Paravalvular Trace/Trivial 10.7 14.7 10.0 2.5
30 Day Paravalvular Mild 10.7 48.7 15.0 18.5
30 Day Paravalvular Mild-Moderate 0.0 0.0 0.0 0.0
30 Day Paravalvular Moderate 0.4 7.2 1.0 1.5
30 Day Paravalvular Moderate-Severe 0.2 0.0 0.0 0.0
30 Day Paravalvular Severe 0.0 0.0 0.0 0.0
30 Day Paravalvular Moderate or Greater 0.6 7.2 1.0 1.5
30 Day Paravalvular AR but Severity not evaluable 5.5 4.9 4.0 4.7
6 Month Paravalvular – Trace or Greater 22.3 62.7 23.8 26.9
6 Month Paravalvular None 77.7 37.3 76.2 73.1
6 Month Paravalvular Trace/Trivial 4.2 6.8 7.1 4.3
6 Month Paravalvular Mild 11.5 42.4 14.3 19.8
6 Month Paravalvular Mild-Moderate 0.0 0.0 0.0 0.0
6 Month Paravalvular Moderate 0.4 4.7 0.0 0.0
6 Month Paravalvular Moderate-Severe 0.2 0.0 0.0 0.0
6 Month Paravalvular Severe 0.0 0.0 0.0 0.0
6 Month Paravalvular Moderate or Greater 0.6 4.7 0.0 0.0
6 Month Paravalvular AR but Severity not evaluable 5.9 8.9 2.4 2.8
1 Year Paravalvular – Trace or Greater 20.1 63.0 24.4 20.6
1 Year Paravalvular None 79.9 37.0 75.6 79.4
1 Year Paravalvular Trace/Trivial 5.7 10.5 4.7 3.3
1 Year Paravalvular Mild 11.3 38.8 14.0 12.3
1 Year Paravalvular Mild-Moderate 0.0 0.0 0.0 0.0
1 Year Paravalvular Moderate 0.9 5.9 0.0 1.2
1 Year Paravalvular Moderate-Severe 0.0 0.9 0.0 0.0
1 Year Paravalvular Severe 0.0 0.0 0.0 0.0
1 Year Paravalvular Moderate or Greater 0.9 6.8 0.0 1.2
1 Year Paravalvular AR but Severity not evaluable 2.2 6.8 5.8 3.7
14.Other Pre-specified Outcome
Title Health Status as Evaluated by Quality of Life Questionnaires
Hide Description

SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year

  • SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
  • Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.

Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Time Frame Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline SF-12 Physical Summary Score 31.9  (9.0) 31.2  (8.9) 33.8  (10.5) 32.4  (10.0)
Baseline SF-12 Mental Health Summary Score 49.6  (11.6) 49.0  (11.6) 49.8  (11.0) 50.0  (11.4)
Baseline KC Overall Summary Score 51.9  (23.5) 50.7  (22.1) 52.7  (24.6) 53.5  (22.8)
Baseline KC Clinical Summary Score 55.2  (23.3) 54.9  (21.9) 57.3  (23.7) 57.6  (22.6)
30 Day change from Baseline SF-12 Physical Summary 5.1  (10.5) 6.0  (10.0) 3.3  (10.5) 4.3  (9.8)
30 Day change from Baseline SF-12 Mental Health S 3.4  (12.5) 2.3  (12.6) 1.8  (11.3) 3.2  (10.6)
30 Day change from Baseline KC Overall Summary 20.9  (24.2) 20.2  (24.0) 17.4  (25.6) 18.3  (23.1)
30 Day change from Baseline KC Clinical Summary 17.4  (23.9) 16.6  (22.9) 15.2  (24.5) 14.8  (22.2)
6M change from Baseline SF-12 Physical Summary 5.8  (10.8) 5.6  (10.1) 3.6  (9.8) 4.7  (10.7)
6M change from Baseline SF-12 Mental Health Sum 3.3  (11.2) 3.3  (12.6) 2.8  (10.5) 3.3  (11.6)
6M change from Baseline KC Overal Summary Score 22.9  (23.8) 22.7  (22.6) 23.5  (25.5) 21.2  (23.1)
6M change from Baseline KC Clinical Summary Score 17.8  (22.7) 17.0  (22.2) 17.5  (24.0) 15.9  (22.2)
1Y change from Baseline SF-12 Physical Summary 4.7  (10.9) 5.2  (10.1) 3.0  (10.8) 3.7  (10.6)
1Y change from Baseline SF-12 Mental Health Sum 3.5  (11.5) 3.7  (12.9) 3.2  (12.5) 3.0  (11.1)
1Y change from Baseline KC Overall Summary Score 21.6  (24.4) 21.4  (23.2) 23.2  (26.7) 20.0  (22.2)
1Y change from Baseline KC Clinical Summary Score 16.3  (23.8) 15.0  (21.5) 15.6  (26.8) 14.0  (21.7)
15.Other Pre-specified Outcome
Title Percentage of Participants With Mortality
Hide Description All-cause, Cardiovascular, and Non-cardiovascular
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge All Cause Mortality Number Analyzed 607 participants 305 participants 102 participants 295 participants
1.3 2.0 0.0 2.0
Discharge Cardiovascular Mortality Number Analyzed 607 participants 305 participants 102 participants 295 participants
1.3 2.0 0.0 2.0
Discharge Non-Cardiovascular Mortality Number Analyzed 607 participants 305 participants 102 participants 295 participants
0.0 0.0 0.0 0.0
30 Day All Cause Mortality Number Analyzed 601 participants 303 participants 102 participants 295 participants
2.5 2.3 0.0 3.4
30 Day Cardiovascular Mortality Number Analyzed 601 participants 303 participants 102 participants 295 participants
2.3 2.3 0.0 3.4
30 Day Non-Cardiovascular Mortality Number Analyzed 601 participants 303 participants 102 participants 295 participants
0.2 0.0 0.0 0.0
6 Month All Cause Mortality Number Analyzed 594 participants 300 participants 102 participants 295 participants
7.7 8.3 8.8 7.1
6 Month Cardiovascular Mortality Number Analyzed 594 participants 300 participants 102 participants 295 participants
5.6 6.7 5.9 4.7
6 Month Non-Cardiovascular Mortality Number Analyzed 594 participants 300 participants 102 participants 295 participants
2.2 1.7 2.9 2.4
1 Year All Cause Mortality Number Analyzed 587 participants 297 participants 101 participants 293 participants
11.9 13.5 12.9 9.2
1 Year Cardiovascular Mortality Number Analyzed 587 participants 297 participants 101 participants 293 participants
7.7 9.8 7.9 5.8
1 Year Non-Cardiovascular Mortality Number Analyzed 587 participants 297 participants 101 participants 293 participants
4.3 3.7 5.0 3.4
16.Other Pre-specified Outcome
Title Percentage of Participants With Stroke
Hide Description Disabling Stroke and Non-disabling Stroke
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Hide Outcome Measure Data
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge All Stroke 4.4 4.3 3.9 5.4
Discharge Disabling Stroke 1.8 3.3 3.9 3.7
Discharge Non-Disabling Stroke 2.6 1.0 0.0 1.7
30 Day All Stroke 4.8 4.3 4.9 6.8
30 Day Disabling Stroke 2.0 3.3 3.9 4.4
30 Day Non-Disabling Stroke 2.8 1.0 1.0 2.4
6 Month All Stroke 5.9 8.3 6.9 8.1
6 Month Disabling Stroke 2.7 6.3 5.9 5.4
6 Month Non-Disabling Stroke 3.2 2.0 1.0 2.7
1 Year All Stroke 7.0 9.4 7.9 8.5
1 Year Disabling Stroke 3.6 7.1 5.9 5.8
1 Year Non-Disabling Stroke 3.6 2.4 2.0 2.7
17.Other Pre-specified Outcome
Title Percentage of Participants With Myocardial Infarction (MI)
Hide Description Periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge Myocardial Infarction 0.5 1.6 2.0 0.7
Discharge Peri-procedural MI 0.5 1.3 2.0 0.7
Discharge Spontaneous MI 0.0 0.3 0.0 0.0
30 Day Myocardial Infarction 0.7 1.3 2.0 1.0
30 Day Peri-procedural MI 0.5 1.0 2.0 0.7
30 Day Spontaneous MI 0.2 0.3 0.0 0.3
6 Month Myocardial Infarction 2.0 3.0 2.9 3.7
6 Month Peri-procedural MI 0.5 1.3 2.0 0.7
6 Month Spontaneous MI 1.5 2.0 1.0 3.1
1 Year Myocardial Infarction 3.2 4.4 5.0 4.4
1 Year Peri-procedural MI 0.5 1.3 2.0 0.7
1 Year Spontaneous MI 2.7 3.4 3.0 3.8
18.Other Pre-specified Outcome
Title Percentage of Participants With Bleeding
Hide Description

Life-threatening (or disabling) and major (defined below)

Life-threatening or Disabling Bleeding

  • Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)
  • Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)
  • Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)
  • Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)

Major Bleeding (BARC type 3a)

  • Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge Bleeding 11.9 10.5 8.8 9.5
Discharge Life-threatening or Disabling Bleeding 7.2 5.9 7.8 5.4
Discharge Major Bleeding 4.6 4.6 1.0 4.1
30 Day Bleeding 12.8 10.9 11.8 11.9
30 Day Life-threatening or Disabling Bleeding 8.0 5.0 9.8 6.1
30 Day Major Bleeding 4.8 5.9 2.0 5.8
6 Month Bleeding 16.5 17.0 17.6 14.9
6 Month Life-threatening or Disabling Bleeding 9.3 9.0 14.7 8.5
6 Month Major Bleeding 7.2 8.0 2.9 6.8
1 Year Bleeding 18.1 17.8 20.8 19.1
1 Year Life-threatening or Disabling Bleeding 9.9 9.8 16.8 11.3
1 Year Major Bleeding 8.3 8.4 5.0 8.9
19.Other Pre-specified Outcome
Title Percentage of Participants With Acute Kidney Injury
Hide Description

Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2

Change in serum creatinine (up to 7 days) compared to baseline:

  • Stage 1: Increase in serum creatinine to 150–199% (1.5–1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)
  • Stage 2: Increase in serum creatinine to 200–299% (2.0–2.99 × increase compared with baseline)
  • Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)

-OR-

Based on urine output (up to 7 days):

  • Stage 1: <0.5 ml/kg per hour for >6 but <12 hours
  • Stage 2: <0.5 ml/kg per hour for >12 but <24 hours
  • Stage 3: <0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours

Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.

Time Frame ≤7 days post index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Acute Kidney Injury – Stage 2 or Stage 3 2.3 3.6 1.0 0.7
Stage 2 1.0 1.3 0.0 0.0
Stage 3 (including renal replacement therapy) 1.3 2.3 1.0 0.7
20.Other Pre-specified Outcome
Title Percentage of Participants With Major Vascular Complication
Hide Description Major vascular complication - including access site related and non access site related
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge Major Vascular Complications 6.8 5.6 8.8 7.8
Discharge Access Site Related 4.6 3.6 6.9 4.4
Discharge Not Access Site Related 2.3 2.0 2.9 3.4
30 Day Major Vascular Complications 7.0 5.3 8.8 7.8
30 Day Access Site Related 4.7 3.3 6.9 4.4
30 Day Not Access Site Related 2.5 2.0 2.9 3.4
6 Month Major Vascular Complications 7.6 5.7 8.8 8.1
6 Month Access Site Related 5.1 3.7 6.9 4.4
6 Month Not Access Site Related 2.7 2.0 2.9 3.7
1 Year Major Vascular Complications 7.7 6.1 8.9 8.2
1 Year Access Site Related 5.1 3.7 6.9 4.8
1 Year Not Access Site Related 2.7 2.4 3.0 3.8
21.Other Pre-specified Outcome
Title Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
Hide Description Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
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Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge Repeat proc valve-related dysfunction 0.0 0.7 1.0 0.3
30 Day Repeat proc valve-related dysfunction 0.0 1.0 1.0 0.7
6 Month Repeat proc valve-related dysfunction 0.2 1.7 1.0 1.0
1 Year Repeat proc valve-related dysfunction 0.2 2.0 1.0 1.0
22.Other Pre-specified Outcome
Title Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
Hide Description Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge 0.8 0.7 1.0 0.0
30 Day 1.7 3.0 4.9 2.4
6 Month 6.7 9.3 9.8 6.4
1 Year 11.2 13.8 13.9 9.6
23.Other Pre-specified Outcome
Title Percentage of Participants With New Permanent Pacemaker Implantation
Hide Description New permanent pacemaker implantation resulting from new or worsened conduction disturbances
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge 28.2 14.8 27.5 24.1
30 Day 29.1 15.8 28.4 28.1
6 Month 33.3 18.0 29.4 30.2
1 Year 34.2 18.5 30.7 31.1
24.Other Pre-specified Outcome
Title Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
Hide Description New onset of atrial fibrillation or atrial flutter
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge 6.4 3.9 4.9 5.1
30 Day 5.8 4.3 5.9 5.1
6 Month 6.6 4.7 5.9 5.1
1 Year 6.6 4.7 5.9 5.1
25.Other Pre-specified Outcome
Title Percentage of Participants With Coronary Obstruction
Hide Description Coronary obstruction
Time Frame ≤72 hours post index procedure
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
0.2 0.7 1.0 0.7
26.Other Pre-specified Outcome
Title Percentage of Participants With Ventricular Septal Perforation
Hide Description Ventricular septal perforation
Time Frame ≤72 hours post index procedure
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participant
0.2 0.0 0.0 0.0
27.Other Pre-specified Outcome
Title Percentage of Participants With Mitral Apparatus Damage
Hide Description Mitral apparatus damage
Time Frame ≤72 hours post index procedure
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
0.0 0.3 0.0 0.0
28.Other Pre-specified Outcome
Title Percentage of Participants With Cardiac Tamponade
Hide Description Cardiac tamponade
Time Frame ≤72 hours post index procedure
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
2.5 1.3 2.0 1.4
29.Other Pre-specified Outcome
Title Percentage of Participants With Prosthetic Aortic Valve Malpositioning
Hide Description Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge Prosthetic aortic valve malpositioning 0.0 2.6 0.0 0.0
Discharge Valve Migration 0.0 0.7 0.0 0.0
Discharge Valve Embolization 0.0 2.0 0.0 0.0
Discharge Ectopic Valve Deployment (Procedural) 0.0 0.3 0.0 0.0
30 Day Prosthetic aortic valve malpositioning 0.0 2.6 0.0 0.0
30 Day Valve Migration 0.0 0.7 0.0 0.0
30 Day Valve Embolization 0.0 2.0 0.0 0.0
30 Day Ectopic Valve Deployment (Procedural) 0.0 0.3 0.0 0.0
6 Month Prosthetic aortic valve malpositioning 0.0 2.7 0.0 0.0
6 Month Valve Migration 0.0 0.7 0.0 0.0
6 Month Valve Embolization 0.0 2.0 0.0 0.0
6 Month Ectopic Valve Deployment (Procedural) 0.0 0.3 0.0 0.0
1 Year Prosthetic aortic valve malpositioning 0.0 2.7 0.0 0.0
1 Year Valve Migration 0.0 0.7 0.0 0.0
1 Year Valve Embolization 0.0 2.0 0.0 0.0
1 Year Ectopic Valve Deployment (Procedural) 0.0 0.3 0.0 0.0
30.Other Pre-specified Outcome
Title Percentage of Participants With Prosthetic Aortic Valve Thrombosis
Hide Description Prosthetic aortic valve thrombosis
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge 0.0 0.0 0.0 1.0
30 Day 0.0 0.0 1.0 1.4
6 Month 1.2 0.0 3.9 2.0
1 Year 1.5 0.0 6.9 2.4
31.Other Pre-specified Outcome
Title Percentage of Participants With Prosthetic Aortic Valve Endocarditis
Hide Description Prosthetic aortic valve endocarditis
Time Frame assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
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Intent to Treat
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Overall Number of Participants Analyzed 607 305 102 295
Measure Type: Number
Unit of Measure: Percentage of participants
Discharge 0.0 0.0 0.0 0.0
30 Day 0.2 0.0 0.0 0.0
6 Month 0.5 0.0 3.9 0.3
1 Year 0.7 0.0 4.0 0.3
Time Frame 1 Year
Adverse Event Reporting Description

For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up).

For the SAE/AE tables, the at risk population (denominator) is the full ITT population.

 
Arm/Group Title Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Hide Arm/Group Description

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System

CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)

All-Cause Mortality
Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   70/587 (11.93%)      40/297 (13.47%)      13/101 (12.87%)      27/293 (9.22%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lotus Valve System - Randomized CoreValve TAVR System - Randomized Lotus Valve System - Single-arm Roll-in Cohort Lotus Valve System - Single-arm Continued Access Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   431/607 (71.00%)      207/305 (67.87%)      72/102 (70.59%)      229/295 (77.63%)    
Blood and lymphatic system disorders         
Anaemia  1  27/607 (4.45%)  27 5/305 (1.64%)  5 4/102 (3.92%)  4 8/295 (2.71%)  8
Haemorrhagic anaemia  1  8/607 (1.32%)  8 9/305 (2.95%)  9 0/102 (0.00%)  0 6/295 (2.03%)  6
Thrombocytopenia  1  5/607 (0.82%)  5 1/305 (0.33%)  1 3/102 (2.94%)  3 9/295 (3.05%)  9
Iron deficiency anaemia  1  2/607 (0.33%)  2 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Heparin-induced thrombocytopenia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Leukocytosis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 2/295 (0.68%)  2
Disseminated intravascular coagulation  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Anaemia macrocytic  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Anaemia of malignant disease  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Coagulopathy  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Haemolytic anaemia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Pancytopenia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Cardiac disorders         
Atrioventricular block complete  1  135/607 (22.24%)  135 37/305 (12.13%)  37 19/102 (18.63%)  19 62/295 (21.02%)  62
Cardiac failure congestive  1  62/607 (10.21%)  75 38/305 (12.46%)  54 11/102 (10.78%)  14 23/295 (7.80%)  24
Atrial fibrillation  1  28/607 (4.61%)  28 7/305 (2.30%)  7 6/102 (5.88%)  6 17/295 (5.76%)  20
Bundle branch block left  1  22/607 (3.62%)  22 9/305 (2.95%)  9 8/102 (7.84%)  8 15/295 (5.08%)  15
Cardiac arrest  1  16/607 (2.64%)  16 4/305 (1.31%)  4 3/102 (2.94%)  4 7/295 (2.37%)  8
Cardiac failure  1  13/607 (2.14%)  15 7/305 (2.30%)  7 1/102 (0.98%)  1 4/295 (1.36%)  4
Atrioventricular block  1  14/607 (2.31%)  14 9/305 (2.95%)  9 7/102 (6.86%)  7 5/295 (1.69%)  5
Acute myocardial infarction  1  12/607 (1.98%)  13 8/305 (2.62%)  8 0/102 (0.00%)  0 11/295 (3.73%)  11
Conduction disorder  1  12/607 (1.98%)  12 8/305 (2.62%)  8 1/102 (0.98%)  1 5/295 (1.69%)  5
Bradycardia  1  9/607 (1.48%)  9 3/305 (0.98%)  3 1/102 (0.98%)  1 7/295 (2.37%)  7
Pericardial effusion  1  9/607 (1.48%)  9 5/305 (1.64%)  5 1/102 (0.98%)  1 4/295 (1.36%)  4
Atrioventricular block second degree  1  8/607 (1.32%)  8 3/305 (0.98%)  3 0/102 (0.00%)  0 7/295 (2.37%)  7
Sick sinus syndrome  1  8/607 (1.32%)  8 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Angina pectoris  1  6/607 (0.99%)  6 8/305 (2.62%)  8 1/102 (0.98%)  1 4/295 (1.36%)  4
Cardiac tamponade  1  5/607 (0.82%)  5 1/305 (0.33%)  1 1/102 (0.98%)  1 1/295 (0.34%)  1
Cardiac failure chronic  1  3/607 (0.49%)  5 3/305 (0.98%)  4 1/102 (0.98%)  1 4/295 (1.36%)  4
Atrioventricular block first degree  1  4/607 (0.66%)  4 1/305 (0.33%)  1 0/102 (0.00%)  0 2/295 (0.68%)  2
Myocardial infarction  1  4/607 (0.66%)  4 3/305 (0.98%)  3 3/102 (2.94%)  3 4/295 (1.36%)  4
Ventricular fibrillation  1  3/607 (0.49%)  3 1/305 (0.33%)  1 1/102 (0.98%)  1 3/295 (1.02%)  3
Mitral valve incompetence  1  2/607 (0.33%)  3 1/305 (0.33%)  1 2/102 (1.96%)  3 1/295 (0.34%)  1
Angina unstable  1  3/607 (0.49%)  3 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Cardio-respiratory arrest  1  3/607 (0.49%)  3 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Cardiogenic shock  1  3/607 (0.49%)  3 3/305 (0.98%)  3 0/102 (0.00%)  0 0/295 (0.00%)  0
Cardiac valve disease  1  3/607 (0.49%)  3 0/305 (0.00%)  0 1/102 (0.98%)  1 3/295 (1.02%)  3
Cardiac failure acute  1  3/607 (0.49%)  3 1/305 (0.33%)  1 2/102 (1.96%)  2 1/295 (0.34%)  1
Cardiomyopathy  1  2/607 (0.33%)  2 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Coronary artery stenosis  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Atrial flutter  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 2/295 (0.68%)  3
Ventricular tachycardia  1  2/607 (0.33%)  2 3/305 (0.98%)  3 1/102 (0.98%)  1 1/295 (0.34%)  1
Acute coronary syndrome  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Left ventricular dysfunction  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Pericarditis  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Nodal rhythm  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 2/295 (0.68%)  2
Mitral perforation  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Intracardiac thrombus  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Electromechanical dissociation  1  1/607 (0.16%)  1 1/305 (0.33%)  1 1/102 (0.98%)  1 0/295 (0.00%)  0
Bundle branch block right  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Myocardial rupture  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Stress cardiomyopathy  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Aortic valve stenosis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 1/102 (0.98%)  1 3/295 (1.02%)  3
Aortic valve incompetence  1  1/607 (0.16%)  1 5/305 (1.64%)  5 0/102 (0.00%)  0 0/295 (0.00%)  0
Coronary artery thrombosis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Myocardial ischaemia  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Sinus arrhythmia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Sinus arrest  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Coronary artery occlusion  1  1/607 (0.16%)  1 2/305 (0.66%)  2 0/102 (0.00%)  0 0/295 (0.00%)  0
Supraventricular tachycardia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Sinus tachycardia  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Sinus bradycardia  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Ischaemic cardiomyopathy  1  0/607 (0.00%)  0 2/305 (0.66%)  2 0/102 (0.00%)  0 0/295 (0.00%)  0
Coronary artery disease  1  0/607 (0.00%)  0 2/305 (0.66%)  2 0/102 (0.00%)  0 1/295 (0.34%)  1
Aortic valve disease  1  0/607 (0.00%)  0 0/305 (0.00%)  0 2/102 (1.96%)  2 1/295 (0.34%)  1
Arrhythmia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Arrhythmia supraventricular  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 1/295 (0.34%)  1
Atrial tachycardia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Atrial thrombosis  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Bradyarrhythmia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Mitral valve calcification  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Mitral valve disease  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Tricuspid valve incompetence  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Trifascicular block  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Ventricular asystole  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Congenital, familial and genetic disorders         
Peutz-Jeghers syndrome  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Ear and labyrinth disorders         
Vertigo  1  0/607 (0.00%)  0 3/305 (0.98%)  3 0/102 (0.00%)  0 0/295 (0.00%)  0
Deafness  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Endocrine disorders         
Hypothyroidism  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Eye disorders         
Cataract  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Vision blurred  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Vitreous haemorrhage  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastrointestinal disorders         
Gastrointestinal haemorrhage  1  12/607 (1.98%)  12 9/305 (2.95%)  9 5/102 (4.90%)  5 10/295 (3.39%)  11
Upper gastrointestinal haemorrhage  1  5/607 (0.82%)  5 2/305 (0.66%)  2 1/102 (0.98%)  1 2/295 (0.68%)  2
Lower gastrointestinal haemorrhage  1  2/607 (0.33%)  3 4/305 (1.31%)  4 0/102 (0.00%)  0 0/295 (0.00%)  0
Inguinal hernia  1  3/607 (0.49%)  3 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Ileus  1  3/607 (0.49%)  3 0/305 (0.00%)  0 1/102 (0.98%)  1 1/295 (0.34%)  1
Diverticulum  1  3/607 (0.49%)  3 1/305 (0.33%)  1 1/102 (0.98%)  1 0/295 (0.00%)  0
Haemorrhoids  1  3/607 (0.49%)  3 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Small intestinal obstruction  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Intestinal obstruction  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Dysphagia  1  2/607 (0.33%)  2 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Haemorrhoidal haemorrhage  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Diarrhoea  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Colitis ischaemic  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Abdominal pain  1  2/607 (0.33%)  2 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Vomiting  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Peptic ulcer haemorrhage  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Umbilical hernia, obstructive  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Pancreatitis acute  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Pancreatitis  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Oesophagitis haemorrhagic  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Oesophageal spasm  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Melaena  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Intestinal mass  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Intestinal ischaemia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Inguinal hernia, obstructive  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Haematemesis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastrointestinal ulcer  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastrointestinal disorder  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastritis erosive  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastric antral vascular ectasia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Constipation  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Colonic polyp  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Colitis  1  1/607 (0.16%)  1 2/305 (0.66%)  2 0/102 (0.00%)  0 1/295 (0.34%)  1
Ascites  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Abdominal pain upper  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Retroperitoneal haematoma  1  1/607 (0.16%)  1 0/305 (0.00%)  0 1/102 (0.98%)  1 1/295 (0.34%)  1
Abdominal hernia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Retroperitoneal haemorrhage  1  1/607 (0.16%)  1 4/305 (1.31%)  4 1/102 (0.98%)  1 3/295 (1.02%)  3
Rectal prolapse  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Rectal haemorrhage  1  0/607 (0.00%)  0 2/305 (0.66%)  2 1/102 (0.98%)  1 3/295 (1.02%)  3
Enterocolitis haemorrhagic  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Enterocolitis  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Enteritis  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Dyspepsia  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Diverticulum oesophageal  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Coeliac disease  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Abdominal distension  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Abdominal discomfort  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Dental caries  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Diarrhoea haemorrhagic  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Diverticular perforation  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Duodenal ulcer haemorrhage  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Gastric ulcer  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Haematochezia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 2/295 (0.68%)  2
Nausea  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Oesophageal rupture  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Umbilical hernia  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Volvulus  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
General disorders         
Death  1  0/607 (0.00%)  0 0/305 (0.00%)  0 2/102 (1.96%)  2 2/295 (0.68%)  2
Fatigue  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Systemic inflammatory response syndrome  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Catheter site haemorrhage  1  8/607 (1.32%)  8 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Non-cardiac chest pain  1  7/607 (1.15%)  7 4/305 (1.31%)  4 0/102 (0.00%)  0 3/295 (1.02%)  3
Asthenia  1  5/607 (0.82%)  5 1/305 (0.33%)  1 4/102 (3.92%)  4 3/295 (1.02%)  3
Adverse drug reaction  1  3/607 (0.49%)  3 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
General physical health deterioration  1  3/607 (0.49%)  3 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Chest pain  1  3/607 (0.49%)  3 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Catheter site necrosis  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Catheter site haematoma  1  2/607 (0.33%)  2 1/305 (0.33%)  1 2/102 (1.96%)  2 8/295 (2.71%)  8
Pain  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Catheter site related reaction  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Catheter site pain  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Sudden cardiac death  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Pyrexia  1  1/607 (0.16%)  1 2/305 (0.66%)  2 0/102 (0.00%)  0 3/295 (1.02%)  3
Oedema peripheral  1  1/607 (0.16%)  1 3/305 (0.98%)  3 0/102 (0.00%)  0 1/295 (0.34%)  1
Implant site haemorrhage  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Implant site haematoma  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Impaired healing  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Hernia obstructive  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Multi-organ failure  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Mechanical complication of implant  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  1
Ischaemic hepatitis  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Hepatic cirrhosis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Cholecystitis acute  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Cholangitis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Biliary dilatation  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Bile duct stone  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Bile duct obstruction  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Liver injury  1  0/607 (0.00%)  0 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Hepatic failure  1  0/607 (0.00%)  0 1/305 (0.33%)  1 1/102 (0.98%)  1 1/295 (0.34%)  1
Alcoholic liver disease  1  0/607 (0.00%)  0 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Immune system disorders         
Anaphylactic reaction  1  0/607 (0.00%)  0 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Infections and infestations         
Pneumonia  1  23/607 (3.79%)  25 13/305 (4.26%)  14 4/102 (3.92%)  4 15/295 (5.08%)  16
Sepsis  1  18/607 (2.97%)  18 5/305 (1.64%)  5 1/102 (0.98%)  1 7/295 (2.37%)  7
Urinary tract infection  1  10/607 (1.65%)  10 9/305 (2.95%)  9 4/102 (3.92%)  5 9/295 (3.05%)  11
Septic shock  1  6/607 (0.99%)  6 4/305 (1.31%)  4 1/102 (0.98%)  1 3/295 (1.02%)  3
Cellulitis  1  5/607 (0.82%)  5 2/305 (0.66%)  2 4/102 (3.92%)  4 2/295 (0.68%)  2
Bronchitis  1  4/607 (0.66%)  4 2/305 (0.66%)  2 0/102 (0.00%)  0 0/295 (0.00%)  0
Endocarditis  1  4/607 (0.66%)  4 2/305 (0.66%)  2 2/102 (1.96%)  2 1/295 (0.34%)  1
Urosepsis  1  3/607 (0.49%)  4 1/305 (0.33%)  1 3/102 (2.94%)  3 2/295 (0.68%)  2
Catheter site infection  1  3/607 (0.49%)  3 1/305 (0.33%)  1 0/102 (0.00%)  0 1/295 (0.34%)  2
Staphylococcal sepsis  1  3/607 (0.49%)  3 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Bacteraemia  1  3/607 (0.49%)  3 1/305 (0.33%)  1 1/102 (0.98%)  1 4/295 (1.36%)  4
Clostridium difficile colitis  1  2/607 (0.33%)  2 1/305 (0.33%)  1 0/102 (0.00%)  0 2/295 (0.68%)  2
Catheter site cellulitis  1  1/607 (0.16%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Staphylococcal infection  1  2/607 (0.33%)  2 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Bacterial sepsis  1  2/607 (0.33%)  2 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Bronchiectasis  1  1/607 (0.16%)  1 1/305 (0.33%)  1 0/102 (0.00%)  0 0/295 (0.00%)  0
Osteomyelitis acute  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Pneumococcal sepsis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Bronchopneumonia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Cellulitis staphylococcal  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Cholecystitis infective  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastrointestinal infection  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Clostridial infection  1  1/607 (0.16%)  1 0/305 (0.00%)  0 1/102 (0.98%)  1 0/295 (0.00%)  0
Clostridium colitis  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Pneumonia klebsiella  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Staphylococcal bacteraemia  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 1/295 (0.34%)  1
Wound infection  1  1/607 (0.16%)  1 0/305 (0.00%)  0 0/102 (0.00%)  0 0/295 (0.00%)  0
Gastroenteritis  1  1/607 (0.16%)  1 2/305 (0.66%)  2 0/102 (0.00%)  0 0/295 (0.00%)  0
Device related infection  1  1/607 (0.16%)  1 1/305 (0.33%)  1