Cardioband With Transfemoral Delivery System

Not Applicable

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Single	Cardioband	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Performance [MLHFQ]	Baseline, 6 and 12 months	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.
Performance [Intra-subject Comparison - MR Severity]	Baseline, discharge, 6 and 12 months	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).
Performance [Full Analysis Data Set - MR Severity]	Baseline, discharge, 6 and 12 months	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).
Performance [6MWT]	Baseline, 6 and 12 months	Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.

Locations (11): Hôpital Bichat-Claude Bernard
🇫🇷
Paris, France
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
🇩🇪
Bonn, Germany
Asklepios Klinik, St. Georg
🇩🇪
Hamburg, Germany
Zentrum für Kardiologie, Universitätsmedizin Mainz
🇩🇪
Mainz, Germany
Rambam Cardiology Research Unit
🇮🇱
Haifa, Israel
St.Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
🇮🇹
Catania, Italy
San Raffaele University Hospital
🇮🇹
Milano, Italy
UniversitätsSpital Zürich
🇨🇭
Zurich, Switzerland
Universitätskliniken zu Köln Klinik III Innere Medizin
🇩🇪
Köln, Germany
Munich University Clinic
🇩🇪
Munich, Germany