Back to resultsREPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System (REPAIR)
Primary Purpose
Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardioband
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Valtech Cardio, Cardioband, Mitral Valve
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Severe (3+ to 4+) secondary Mitral Regurgitation
- Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
- The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
- Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
- Subject is willing and able to provide informed consent and follow protocol
Exclusion Criteria:
- EF < 20%
- LVEDD ≥ 70 mm
- Heavily calcified annulus or leaflets
- Significant CAD requiring revascularization
- Active bacterial endocarditis
- Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- Renal insufficiency requiring dialysis
- Life expectancy of less than twelve months
- Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
- Pulmonary hypertension ≥ 70mmHg at rest
- Mitral valve anatomy which may preclude proper device treatment
- Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
- Severe liver disease
- Patient is pregnant or lactating
- Hypersensitivity to Nickel or Chromium
- Clinically significant bleeding diathesis or coagulopathy
- History of mitral valve repair
- TIA or CVA within 3 months
Sites / Locations
- Bichat hospital
- Bad Nauheim, Kerckhoff-Klinik
- Bonn University
- Universitätsklinikum Gießen und Marburg
- University Hospital Halle (Saale)
- Asklepios Klinik, St. Georg
- Universitäres Herzzentrum Hamburg GmbH
- Koln, Universitätsklinikum
- Universitatsmedizin Mainz
- Hospital san raffaele
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardioband procedure
Arm Description
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Outcomes
Primary Outcome Measures
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Secondary Outcome Measures
Change in Distance Walked on 6 Minute Walk Test
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Change in Mitral Regurgitation Severity
Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Full Information
NCT ID
NCT02703311
First Posted
February 22, 2016
Last Updated
October 16, 2020
Sponsor
Edwards Lifesciences
1. Study Identification
Unique Protocol Identification Number
NCT02703311
Brief Title
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
Acronym
REPAIR
Official Title
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete.
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.
Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Mitral Regurgitation
Keywords
Valtech Cardio, Cardioband, Mitral Valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardioband procedure
Arm Type
Other
Arm Description
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Intervention Type
Device
Intervention Name(s)
Cardioband
Intervention Description
Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Primary Outcome Measure Information:
Title
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Description
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Change in Distance Walked on 6 Minute Walk Test
Description
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Time Frame
6 months over Baseline
Title
Change in Mitral Regurgitation Severity
Description
Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Time Frame
6, 12, and 24 months over baseline
Other Pre-specified Outcome Measures:
Title
Change in Distance Walked on 6 Minute Walk Test
Description
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline
Time Frame
12, and 24 months over baseline
Title
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
Time Frame
6, 12, and 24 months over baseline
Title
Change in New York Heart Association (NYHA) Class
Description
NYHA Class at 6, 12, and 24 months compared to baseline
Time Frame
6, 12, and 24 months over baseline
Title
Change in Left Ventricular End Diastolic Volume (LVEDV)
Description
Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time Frame
6, 12, and 24 months over baseline
Title
Change in Left Ventricular End Systolic Volume (LVESV)
Description
Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time Frame
6, 12, and 24 months over baselines
Title
Number of Participants With Device Success
Description
Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
Time Frame
Discharge
Title
Number of Participants With Patient Success
Description
Individual patient success (measured at 6 months and 1 year) defined as device success and the following:
Discharged from index hospitalization
NYHA class improvement by at least 1 level from baseline
Time Frame
6 and 12 months
Title
Number of Days Alive and Out of Hospital
Description
Days alive and out of hospital due to major cardiovascular events at 1 year
Time Frame
12 months
Title
Freedom From All-cause Mortality and Major Adverse Events (AE)
Description
Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.
Time Frame
30 days from implant procedure or hospital discharge, whichever is later.
Title
Need for Urgent/Emergent Surgical Intervention
Description
Number of patients who undergo urgent/emergent surgical intervention post procedure
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Severe (3+ to 4+) secondary Mitral Regurgitation
Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
Subject is willing and able to provide informed consent and follow protocol
Exclusion Criteria:
EF < 20%
LVEDD ≥ 70 mm
Heavily calcified annulus or leaflets
Significant CAD requiring revascularization
Active bacterial endocarditis
Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
Renal insufficiency requiring dialysis
Life expectancy of less than twelve months
Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
Pulmonary hypertension ≥ 70mmHg at rest
Mitral valve anatomy which may preclude proper device treatment
Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
Severe liver disease
Patient is pregnant or lactating
Hypersensitivity to Nickel or Chromium
Clinically significant bleeding diathesis or coagulopathy
History of mitral valve repair
TIA or CVA within 3 months
Facility Information:
Facility Name
Bichat hospital
City
Paris
ZIP/Postal Code
18 75877
Country
France
Facility Name
Bad Nauheim, Kerckhoff-Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Bonn University
City
Bonn
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg
City
Giessen
Country
Germany
Facility Name
University Hospital Halle (Saale)
City
Halle
Country
Germany
Facility Name
Asklepios Klinik, St. Georg
City
Hamburg
ZIP/Postal Code
5 20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg GmbH
City
Hamburg
Country
Germany
Facility Name
Koln, Universitätsklinikum
City
Koln
Country
Germany
Facility Name
Universitatsmedizin Mainz
City
Mainz
Country
Germany
Facility Name
Hospital san raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
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