Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair
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ClinicalTrials.gov Identifier: NCT01533883
Recruitment Status : Unknown
Verified August 2016 by Edwards Lifesciences. Recruitment status was: Active, not recruiting
Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. The aim of this study is to evaluate the performance and safety of the Cardioband for repair of mitral regurgitation.
Condition or disease
Mitral Valve Insufficiency
Device: Cardioband adjustable band
The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are reserved to fit patients with low or moderate surgical risk, and thus several patients are refused surgery because of unfavorable risk-benefit balance. Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. Cardioband is intended to remodel the annulus by deployment and fixation along (and direct) the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.
Cardioband is an adjustable sutureless annuloplasty band designed for mitral valve repair by a transfemoral approach. Cardioband is intended to remodel the annulus by deployment and fixation along the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient is a candidate for mitral valve repair: moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction (AHA/ACC criteria)
Age > 18 years
Moderate to severe functional MR
Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including CRT if indicated
LVEF ≥ 25%, LVEDD ≤ 70mm
Subject is high risk to undergo MV surgery (as assessed by a cardiac surgeon and a cardiologist at the site, and according to ESC/EACTS guidelines on the management of valvular heart disease)
Transseptal catheterization and femoral vein access is determined to be feasible
Subject is able and willing to give informed consent and follow protocol procedures
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