Cardioband With Transfemoral Delivery System

Edwards Lifesciences62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Regurgitation

Interventions

CardiobandDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Hôpital Bichat-Claude Bernard

Paris, France

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, Germany

Universitätskliniken zu Köln Klinik III Innere Medizin

Cologne, Germany

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

Performance [6MWT]

Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: Baseline, discharge, 6 and 12 months

Data from ClinicalTrials.gov

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