Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE III)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02202434 |
Recruitment Status :
Terminated
(RCT/Roll-in completed. CAS/21mm/Nested Registry terminated (investigational device is no longer available))
First Posted : July 29, 2014
Results First Posted : July 30, 2019
Last Update Posted : December 17, 2021
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Study Type | Interventional |
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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 | 1425 |
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 |
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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) |
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 | |
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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) |
Total of all reporting groups | |
Overall Number of Baseline Participants | 607 | 305 | 102 | 295 | 1309 | |
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Data are reported separately for each cohort as pooled mean and standard deviations across cohorts do not provide meaningful data.
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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 |
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Number Analyzed | 607 participants | 305 participants | 102 participants | 295 participants | 1309 participants | |
Female |
304 50.1%
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159 52.1%
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52 51.0%
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137 46.4%
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652 49.8%
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Male |
303 49.9%
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146 47.9%
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50 49.0%
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158 53.6%
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657 50.2%
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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%
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0 0.0%
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1 1.0%
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1 0.3%
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3 0.2%
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Asian |
3 0.5%
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2 0.7%
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0 0.0%
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4 1.4%
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9 0.7%
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Black, of African Heritage |
17 2.8%
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11 3.6%
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4 3.9%
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13 4.4%
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45 3.4%
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Caucasian |
537 88.5%
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271 88.9%
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93 91.2%
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271 91.9%
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1172 89.5%
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Hispanic or Latino |
18 3.0%
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2 0.7%
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4 3.9%
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6 2.0%
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30 2.3%
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Native Hawaiian or other Pacific Islander |
2 0.3%
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1 0.3%
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0 0.0%
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0 0.0%
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3 0.2%
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Other |
3 0.5%
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4 1.3%
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0 0.0%
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1 0.3%
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8 0.6%
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Unknown or Not Reported |
28 4.6%
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14 4.6%
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1 1.0%
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0 0.0%
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43 3.3%
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[1]
Measure Description: Subjects were allowed to select more than one option.
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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.
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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.
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New York Heart Association (NYHA) Classification
[1] Measure Type: Count of Participants Unit of measure: Participants |
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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).
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