Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function

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