Cardioband With Transfemoral Delivery System

Study Overview
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Brief Summary
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To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Official Title
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Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: Cardioband


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Moderate to severe functional Mitral Regurgitation (MR) Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated. Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site) Transseptal catheterization and femoral vein access is determined to be feasible Subject is able and willing to give informed consent and follow protocol procedures Exclusion Criteria: Active bacterial endocarditis Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue Heavily calcified annulus or leaflets Subjects in whom transesophageal echocardiography is contraindicated Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization CRT implant within 3 months prior to procedure Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (>70% by Ultra sound) Renal insufficiency requiring dialysis Life expectancy of less than twelve months Subject is participating in concomitant research studies of investigational products Mitral valve anatomy which may preclude proper device treatment Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br> | Device: Cardioband<br> <br> * Other names: With Transfemoral delivery system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects | Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance [6MWT] | Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months. | Baseline, 6 and 12 months | 
| Performance [MLHFQ] | Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life. | Baseline, 6 and 12 months | 
| Performance [Intra-subject Comparison - MR Severity] | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). | Baseline, discharge, 6 and 12 months | 
| Performance [Full Analysis Data Set - MR Severity] | All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe). | Baseline, discharge, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve, Annuloplasty