Cardioband With Transfemoral Delivery System

Edwards Lifesciences

Status: Completed

Conditions: Mitral Regurgitation

Treatments: Device: Cardioband

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841554

CB1-1/CB1-2

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Single

Experimental group

Treatment:

Device: Cardioband