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Inclusion criteria (all must be present) |
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· Symptomatic SMR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology |
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· Subject has been adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, MR and HF |
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· Subject has had at least one hospitalization for HF in the 12 months prior to subject registration and/or a corrected* BNP ≥300 pg/ml or a corrected NT-proBNP ≥1500 pg/ml |
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· New York Heart Association (NYHA) functional class II, III or ambulatory IV |
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· Local heart team has determined that MV surgery will not be offered as a treatment option, even if the subject is randomized to the Control group |
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· Left ventricular ejection fraction (LVEF) ≥20% and ≤50%. |
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· Left ventricular end-systolic dimension (LVESD) ≤70 mm |
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· CK-MB obtained within prior 14 days is < local laboratory ULN |
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· Transseptal catheterization and femoral vein access is feasible per the MitraClip implanting investigator |
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· Age 18 years or older |
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· Subject or guardian agrees to all provisions of the protocol, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent |
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Exclusion criteria (all must be absent) |
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· Untreated clinically significant coronary artery disease requiring revascularization |
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· CABG, PCI or TAVR within the prior 30 days |
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· Aortic or tricuspid valve disease requiring surgery or transcatheter intervention |
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· COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use |
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· Cerebrovascular accident within prior 30 days |
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· Severe symptomatic carotid stenosis (>70% by ultrasound) |
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· Carotid surgery or stenting within prior 30 days |
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· ACC/AHA stage D heart failure |
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· Presence of any of the following: – Estimated PASP >70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the PVR to <3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the PCWP – Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology – Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) – Hemodynamic instability requiring inotropic support or mechanical heart assistance |
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· Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction |
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· Implant of CRT or CRT-D within the last 30 days |
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· Mitral valve orifice area <4.0 cm2 by site-assessed TTE |
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· Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. |
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· Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. |
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· Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. |
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· Life expectancy < 12 months due to non-cardiac conditions |
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· Modified Rankin Scale ≥ 4 disability. |
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· Status 1 heart transplant or prior orthotopic heart transplantation |
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· Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure. |
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· Echocardiographic evidence of intracardiac mass, thrombus or vegetation |
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· Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) |
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· Active infections requiring current antibiotic therapy |
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· Transesophageal echocardiography (TEE) is contraindicated or high risk |
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· Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically |
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· Pregnant or planning pregnancy within next 12 months |
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· Currently participating in an investigational drug or another device study that has not reached its primary endpoint. |
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· Subject belongs to a vulnerable population or has any disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures |
*“Corrected” refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in body mass index above a reference of 20 kg/m2).
Abbreviations: ACC/AHA, American College of Cardiology/American Heart Association; BNP, brain natriuretic peptide; CABG, coronary artery bypass graft; CK-MB, creatine phosphokinase MB isoenzyme; COPD, chronic obstructive pulmonary disease; CRT, cardiac resynchronization therapy; CRT-D, CRT-defibrillator; HF, heart failure; LV, left ventricular; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic dimension; MR, mitral regurgitation; MV, mitral valve; NT-proBNP, N-terminal pro b-type natriuretic peptide; NYHA, New York Heart Association; PASP, pulmonary artery systolic pressure; PCI, percutaneous coronary intervention; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular resistance; SMR, secondary mitral regurgitation; TAVR, transcatheter aortic valve replacement; TEE, transesophageal echocardiography; TTE, transthoracic echocardiography; ULN, upper limit of normal.