percutaneous left ventricular reshaping to reduce functional mitral regurgitation and improve lv function

Conditions: Functional Mitral Regurgitation

Summary: the study is designed to demonstrate the safety, feasibility and potential efficacy of using the accucinch® system to reduce functional mitral regurgitation.


Eligibility criteria:
inclusion criteria: * age \>18 years * subjects with clinically significant mitral regurgitation (mr 2+ and above) * ejection fraction ≥ 25% * stable cardiac medical regimen for heart failure for at least 1 month * stable nyha classification for at least 1 month * subject is eligible for cardiac surgery * the subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent exclusion criteria: * myocardial infarction within 90 days of the intended treatment with the device * prior surgical, transcatheter, or percutaneous mitral valve intervention * any intervention for coronary artery disease (cad) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease * hemodynamic instability or the need for emergent surgery * non-ambulatory nyha class iv symptoms of heart failure or subjects requiring iv inotropic support * subjects in whom sufficient quality of echocardiography (tte and tee) cannot be obtained * echocardiography evidence of primary mitral valve disease causing mr or ms, * evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm2 * mitral valve prosthesis or pathology that would prevent adequate function of the gds accucinch system * estimated gfr of \<30ml/min/1.73m2 * greater than mild mitral annular calcification observed by fluoroscopy * presence of aortic valve prosthesis * moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy * severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy * active bacterial endocarditis * history of bleeding diathesis or coagulopathy * history of stroke within the prior 6 months * subjects in whom anticoagulation is contraindicated * any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device. * concurrent medical condition with a life expectancy of less than 12 months * currently participating in an investigational study * co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities) * subjects with indication for concomitant surgery such as coronary artery bypass graft (cabg), aortic valve reconstruction or replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair * any cardiac resynchronization therapy within the last 3 months prior to treatment * subjects on high dose steroids or immunosuppressant therapy * female subjects who are pregnant, of child bearing potential or lactating * subjects who are unable or unwilling to comply with the follow-up schedule and requirements

Keywords: heart failure mitral regurgitation mitral valve