feasibility of the accucinch® system for left ventricular reshaping of the mitral apparatus to reduce functional mitral regurgitation and improve left ventricular function

Conditions: Severe Functional Mitral Regurgitation and Heart Failure

Summary: to assess the safety and performance of the gds accucinch system when used percutaneously to reduce functional mitral regurgitation.


Eligibility criteria:
inclusion criteria: * age \> 18 years * subjects with severe symptomatic functional mitral regurgitation of ≥ 3+ secondary to left ventricular (lv) remodeling and/or annular remodeling, as measured in accordance with the current ase guidelines and suitable for treatment in accordance with the current aha/acc guidelines: * left ventricular ejection fraction (lvef) ≥ 20% and ≤ 40% * stable cardiac medical regimen for heart failure for at least 1 month * stable nyha classification (class iii and above) for at least 1 month * the subject has been informed of the nature of the study, agrees to its provisions, including the possibility of conversion to surgery, and has provided written informed consent. exclusion criteria: candidates will be excluded from the study if any of the following conditions are present: * myocardial infarction within 90 days of the intended treatment with the device * prior surgical, transcatheter, or percutaneous mitral valve intervention or mitral valve prosthesis * subject has untreated coronary artery disease, which in the opinion of the treating physician and/or heart team, is clinically significant and requires revascularization * non-ambulatory nyha class iv symptoms of heart failure or subjects in cardiogenic shock or with hemodynamic instability requiring iv inotropic support or mechanical support devices * subject has the need for emergent surgery for any reason * subjects in whom sufficient quality of echocardiography (tte and tee) cannot be obtained * echocardiography evidence of primary mitral valve disease causing mr or ms; * moderate to severe pulmonary hypertension (pa systolic pressure ≥ 80 mm hg) as assessed by echocardiography * evidence of mitral valve stenosis with an estimated valve area less than 3.5 cm2 * mitral valve pathology that would prevent adequate function of the gds accucinch system * subject is on dialysis or estimated gfr \< 30ml/min/1.73m2 (cockcroft-gault formula)d d israni ak, et al. laboratory assessment of kidney disease, in brenner and rector's the kidney, 9th ed. chapter 25 * 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 or active sepsis * 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 another investigational drug or device study that has not reached its primary endpoint * 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) * subject with indication for concomitant surgery such as coronary artery bypass graft (cabg), aortic valve reconstruction or replacement, left ventricular remodeling surgery and congenital repair * any cardiac resynchronization therapy within the last 9 months prior to treatment * subject on high dose steroids or immunosuppressant therapy * current problems with substance abuse (e.g. alcohol, illegal drugs, etc.) * female subjects who are pregnant, lactating, or planning pregnancy within next the 36 months. note: childbearing age should be instructed to use safe contraception during their participation in this study. * subjects who are unable or unwilling to comply with the follow-up schedule and requirements * subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to study required medications, to nickel, or to polyurethanes * femoral artery lumen diameter of \< 5.5 mm, or severe ilio-femoral tortuosity or calcification that would prevent safe placement of the 16fr introducer sheath

Keywords: functional mitral regurgitation heart failure ventricular reshaping