Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation

Inclusion Criteria: * Symptomatic ventricular FMR (moderate-to-severe \[grade 3+\] or severe \[4+\] by independent echocardiographic core laboratory assessment) due to cardiomyopathy of either ischemic or non-ischemic etiology (LVEF 30-49%), concomitant with AF * Symptomatic atrial FMR (moderate-to-severe \[grade 3+\] or severe \[4+\] by independent echocardiographic core laboratory assessment) due to AF, with normal (≥50%) LVEF * LV end-systolic diameter ≤70 mm * Documented history of paroxysmal AF (PAF) or persistent AF for maximally 2 years * Subject has been adequately treated medically for at least 4 weeks per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation and heart failure * NYHA functional class II, III or ambulatory IV * Local heart team has determined that MV surgery is not indicated as a treatment option or will be high risk * Age 18-80 years Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization * CABG, PCI or TAVR within prior 30 days * Aortic or tricuspid valve disease (tricuspid regurgitation ≥3+) requiring surgery or transcatheter intervention * Cerebrovascular accident within prior 30 days * Severe symptomatic carotid stenosis (\>70% by ultrasound) * Carotid surgery or stenting within prior 30 days * NYHA functional class IV requiring in-hospital care * Implant of CRT or CRT-D within the last 30 days * Transseptal puncture anatomically not feasible * Leafl…