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REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

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ClinicalTrials.gov Identifier: NCT01627691
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : September 10, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Transcatheter Aortic Valve Replacement
Intervention Device: Lotus Valve System
Enrollment 250
Recruitment Details  
Pre-assignment Details  
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Period Title: Overall Study
Started 250
Primary Endpoint (30days) 239
Completed 232
Not Completed 18
Reason Not Completed
Death             11
Lost to Follow-up             3
Withdrawal by Subject             1
Missed the visit             3
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Baseline Participants 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 250 participants
84.0  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants
Female
131
  52.4%
Male
119
  47.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Unknown or not reported Number Analyzed 250 participants
250
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants
Australia
74
  29.6%
Europe
171
  68.4%
EuroSCORE   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted mortality
Number Analyzed 250 participants
6.4  (6.2)
[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.
STS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 250 participants
6.5  (4.2)
[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."
NYHA Functional Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants
Grade I
0
   0.0%
Grade II
57
  22.8%
Grade III
166
  66.4%
Grade IV
27
  10.8%
[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 Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure
Hide Description Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
As specified, this endpoint was evaluated using data from the first 120 patients enrolled in the study
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: mmHG
11.45  (5.20)
2.Primary Outcome
Title Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure
Hide Description Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 249
Measure Type: Count of Participants
Unit of Measure: Participants
11
   4.4%
3.Secondary Outcome
Title Effective Orifice Area
Hide Description Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with an echocardiography available from the 30-day follow-up visit and analyzable by the Core Lab
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 170
Mean (95% Confidence Interval)
Unit of Measure: square centimeter
1.73
(1.66 to 1.79)
4.Secondary Outcome
Title Device Performance Endpoint: Successful Vascular Access
Hide Description Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 250
Measure Type: Count of Participants
Unit of Measure: Participants
247
  98.8%
5.Secondary Outcome
Title Device Performance Endpoint: Successful Retrieval
Hide Description Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants for whom a retrieval of the valve was attempted
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
12
  92.3%
6.Secondary Outcome
Title Device Performance Endpoint: Successful Repositioning
Hide Description Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants for whom a repositioning of the valve was attempted
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 85
Measure Type: Count of Participants
Unit of Measure: Participants
85
 100.0%
7.Secondary Outcome
Title Device Success According to the Valve Academic Research Consortium (VARC)
Hide Description Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who had an echocardiography available post-procedure for the Core Lab to measure the performance of the prosthetic heart valve as described above
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 175
Measure Type: Count of Participants
Unit of Measure: Participants
96
  54.9%
8.Secondary Outcome
Title Grade of Aortic Valve Regurgitation
Hide Description Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with echocardiography available from the 30-day follow-up visit and analyzable from the Core Lab for those measurements
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description:

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

Overall Number of Participants Analyzed 210
Measure Type: Count of Participants
Unit of Measure: Participants
None
159
  75.7%
Trace/Trivial
18
   8.6%
Mild
31
  14.8%
Mild-moderate
0
   0.0%
Moderate
1
   0.5%
Moderate-Severe
0
   0.0%
Severe
0
   0.0%
Severity not evaluable
1
   0.5%
Time Frame Primary Endpoint (30days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title REPRISE II and Extension Overall
Hide Arm/Group Description

Transcatheter aortic valve replacement (TAVR) with the Lotus™ Valve System.

Lotus Valve System: - bioprosthetic bovine pericardial aortic valve

- delivery system

All-Cause Mortality
REPRISE II and Extension Overall
Affected / at Risk (%)
Total   11/250 (4.40%)    
Hide Serious Adverse Events
REPRISE II and Extension Overall
Affected / at Risk (%) # Events
Total   152/250 (60.80%)    
Blood and lymphatic system disorders   
Total  1  12/250 (4.80%)  12
Anaemia  1  8/250 (3.20%)  8
Haemorrhagic anaemia  1  4/250 (1.60%)  4
Cardiac disorders   
Total  1  97/250 (38.80%)  123
Atrioventricular block complete  1  47/250 (18.80%)  47
Atrial fibrillation  1  7/250 (2.80%)  7
Bundle branch block left  1  7/250 (2.80%)  7
Atrioventricular block  1  6/250 (2.40%)  6
Cardiac tamponade  1  6/250 (2.40%)  6
Cardiac arrest  1  5/250 (2.00%)  5
Atrioventricular block first degree  1  4/250 (1.60%)  4
Cardiac failure  1  4/250 (1.60%)  4
Cardiac failure congestive  1  4/250 (1.60%)  4
Pericardial effusion  1  4/250 (1.60%)  4
Atrioventricular block second degree  1  3/250 (1.20%)  3
Bradycardia  1  2/250 (0.80%)  2
Left ventricular failure  1  2/250 (0.80%)  2
Myocardial infarction  1  2/250 (0.80%)  2
Sick sinus syndrome  1  2/250 (0.80%)  2
Ventricular tachycardia  1  2/250 (0.80%)  2
Aortic valve incompetence  1  1/250 (0.40%)  1
Atrial flutter  1  1/250 (0.40%)  1
Cardiac perforation  1  1/250 (0.40%)  1
Cardio-respiratory arrest  1  1/250 (0.40%)  1
Conduction disorder  1  1/250 (0.40%)  1
Coronary artery thrombosis  1  1/250 (0.40%)  1
Coronary ostial stenosis  1  1/250 (0.40%)  1
Electromechanical dissociation  1  1/250 (0.40%)  1
Mitral valve incompetence  1  1/250 (0.40%)  1
Right ventricular failure  1  1/250 (0.40%)  1
Sinus arrest  1  1/250 (0.40%)  1
Trifascicular block  1  1/250 (0.40%)  1
Ventricle rupture  1  1/250 (0.40%)  1
Ventricular arrhythmia  1  1/250 (0.40%)  1
Ventricular dysfunction  1  1/250 (0.40%)  1
Ventricular fibrillation  1  1/250 (0.40%)  1
Congenital, familial and genetic disorders   
Total  1  1/250 (0.40%)  1
Phimosis  1  1/250 (0.40%)  1
Eye disorders   
Total  1  2/250 (0.80%)  2
Cataract  1  1/250 (0.40%)  1
Eyelid ptosis  1  1/250 (0.40%)  1
Gastrointestinal disorders   
Total  1  8/250 (3.20%)  8
Abdominal pain  1  1/250 (0.40%)  1
Diarrhoea  1  1/250 (0.40%)  1
Gastritis erosive  1  1/250 (0.40%)  1
Haematemesis  1  1/250 (0.40%)  1
Intestinal functional disorder  1  1/250 (0.40%)  1
Melaena  1  1/250 (0.40%)  1
Peritoneal haemorrhage  1  1/250 (0.40%)  1
Retroperitoneal haemorrhage  1  1/250 (0.40%)  1
General disorders   
Total  1  26/250 (10.40%)  28
Catheter site haematoma  1  12/250 (4.80%)  12
Catheter site haemorrhage  1  7/250 (2.80%)  7
Pyrexia  1  3/250 (1.20%)  3
Puncture site haemorrhage  1  2/250 (0.80%)  2
Asthenia  1  1/250 (0.40%)  1
Implant site discharge  1  1/250 (0.40%)  1
Implant site haematoma  1  1/250 (0.40%)  1
Multi-organ failure  1  1/250 (0.40%)  1
Immune system disorders   
Total  1  1/250 (0.40%)  1
Drug hypersensitivity  1  1/250 (0.40%)  1
Infections and infestations   
Total  1  18/250 (7.20%)  18
Pneumonia  1  4/250 (1.60%)  4
Urinary tract infection  1  2/250 (0.80%)  2
Bronchiectasis  1  1/250 (0.40%)  1
Cellulitis  1  1/250 (0.40%)  1
Implant site infection  1  1/250 (0.40%)  1
Infection  1  1/250 (0.40%)  1
Influenza  1  1/250 (0.40%)  1
Lower respiratory tract infection  1  1/250 (0.40%)  1
Osteomyelitis  1  1/250 (0.40%)  1
Puncture site infection  1  1/250 (0.40%)  1
Pyelonephritis  1  1/250 (0.40%)  1
Sepsis  1  1/250 (0.40%)  1
Staphylococcal infection  1  1/250 (0.40%)  1
Viral infection  1  1/250 (0.40%)  1
Injury, poisoning and procedural complications   
Total  1  9/250 (3.60%)  9
Device failure  1  3/250 (1.20%)  3
Vascular pseudoaneurysm  1  2/250 (0.80%)  2
Cardiac pacemaker malfunction  1  1/250 (0.40%)  1
Device migration  1  1/250 (0.40%)  1
Operative haemorrhage  1  1/250 (0.40%)  1
Vascular access complication  1  1/250 (0.40%)  1
Investigations   
Total  1  8/250 (3.20%)  8
Haemoglobin decreased  1  6/250 (2.40%)  6
C-reactive protein increased  1  1/250 (0.40%)  1
Cardiac enzymes increased  1  1/250 (0.40%)  1
Metabolism and nutrition disorders   
Total  1  1/250 (0.40%)  1
Hyponatraemia  1  1/250 (0.40%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Total  1  1/250 (0.40%)  1
Tongue neoplasm malignant stage unspecified  1  1/250 (0.40%)  1
Nervous system disorders   
Total  1  16/250 (6.40%)  19
Cerebrovascular accident  1  6/250 (2.40%)  6
Ischaemic stroke  1  2/250 (0.80%)  2
Cerebellar haematoma  1  1/250 (0.40%)  1
Cerebral haemorrhage  1  1/250 (0.40%)  1
Cognitive disorder  1  1/250 (0.40%)  1
Coma  1  1/250 (0.40%)  1
Embolic stroke  1  1/250 (0.40%)  1
Haemorrhage intracranial  1  1/250 (0.40%)  1
Haemorrhagic stroke  1  1/250 (0.40%)  1
Hemiparesis  1  1/250 (0.40%)  1
Motor neurone disease  1  1/250 (0.40%)  1
Syncope  1  1/250 (0.40%)  1
Transient ischaemic attack  1  1/250 (0.40%)  1
Psychiatric disorders   
Total  1  5/250 (2.00%)  5
Delirium  1  3/250 (1.20%)  3
Confusional state  1  1/250 (0.40%)  1
Disorientation  1  1/250 (0.40%)  1
Renal and urinary disorders   
Total  1  4/250 (1.60%)  4
Bladder disorder  1  1/250 (0.40%)  1
Renal disorder  1  1/250 (0.40%)  1
Renal failure chronic  1  1/250 (0.40%)  1
Urinary retention  1  1/250 (0.40%)  1
Reproductive system and breast disorders   
Total  1  1/250 (0.40%)  1
Oedema genital  1  1/250 (0.40%)  1
Respiratory, thoracic and mediastinal disorders   
Total  1  12/250 (4.80%)  13
Pulmonary oedema  1  3/250 (1.20%)  3
Epistaxis  1  2/250 (0.80%)  2
Haemothorax  1  2/250 (0.80%)  2
Pleural effusion  1  2/250 (0.80%)  2
Acute pulmonary oedema  1  1/250 (0.40%)  1
Chronic obstructive pulmonary disease  1  1/250 (0.40%)  1
Dyspnoea  1  1/250 (0.40%)  1
Pulmonary embolism  1  1/250 (0.40%)  1
Skin and subcutaneous tissue disorders   
Total  1  1/250 (0.40%)  1
Rash  1  1/250 (0.40%)  1
Vascular disorders   
Total  1  27/250 (10.80%)  27
Haemorrhage  1  6/250 (2.40%)  6
Hypotension  1  6/250 (2.40%)  6
Femoral artery dissection  1  5/250 (2.00%)  5
Haematoma  1  3/250 (1.20%)  3
Angiopathy  1  2/250 (0.80%)  2
Arterial haemorrhage  1  1/250 (0.40%)  1
Arterial rupture  1  1/250 (0.40%)  1
Hypertension  1  1/250 (0.40%)  1
Peripheral arterial occlusive disease  1  1/250 (0.40%)  1
Peripheral artery dissection  1  1/250 (0.40%)  1
1
Term from vocabulary, MedDRA (12.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
REPRISE II and Extension Overall
Affected / at Risk (%) # Events
Total   157/250 (62.80%)    
Blood and lymphatic system disorders   
Total  1  17/250 (6.80%)  17
Thrombocytopenia  1  17/250 (6.80%)  17
Cardiac disorders   
Total  1  106/250 (42.40%)  129
Bundle branch block left  1  98/250 (39.20%)  99
Atrioventricular block first degree  1  17/250 (6.80%)  17
Atrial fibrillation  1  13/250 (5.20%)  13
General disorders   
Total  1  61/250 (24.40%)  98
Catheter site haematoma  1  35/250 (14.00%)  48
Catheter site haemorrhage  1  25/250 (10.00%)  26
Pyrexia  1  23/250 (9.20%)  24
Infections and infestations   
Total  1  19/250 (7.60%)  19
Urinary tract infection  1  19/250 (7.60%)  19
Vascular disorders   
Total  1  35/250 (14.00%)  35
Hypertension  1  18/250 (7.20%)  18
Hypotension  1  17/250 (6.80%)  17
1
Term from vocabulary, MedDRA (12.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne Cornaille
Organization: Boston Scientific
Phone: +33608863659
EMail: anne.cornaille@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01627691    
Other Study ID Numbers: TP3687
TP3687 ( Other Identifier: Boston Scientific )
First Submitted: June 5, 2012
First Posted: June 26, 2012
Results First Submitted: May 20, 2019
Results First Posted: September 10, 2019
Last Update Posted: May 12, 2020