Treatment of Functional Mitral Regurgitation in Patients With Atrial Fibrillation (CAMERA-Pilot)

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 Leaflet anatomy which may preclude MitraClip/PASCAL implantation, proper MitraClip/PASCAL positioning on the leaflets, or sufficient reduction in mitral regurgitation by the MitraClip/PASCAL device. Current pregnancy or planned pregnancy within next 12 months