REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Study Overview
=================
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.

Official Title
-----------------
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Conditions
-----------------
Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: Cardioband


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardioband procedure<br>Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance | Device: Cardioband<br>* Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months over Baseline | 
| Change in Mitral Regurgitation Severity | Mitral Regurgitation at 6, 12, and 24 months compared to baseline | 6, 12, and 24 months over baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardioband, Mitral Valve, Valtech Cardio