Capstan Medical TMVR Study: FIH

This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.

Inclusion Criteria: * Age ≥ 18 years at the time of consent. * Moderate-severe (3+) or severe (4+) mitral regurgitation * NYHA II or greater symptoms despite optimal medical treatment. * The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER). * Ability and willingness to provide written informed consent prior to any study related procedure(s). Exclusion Criteria: * LVEF less than 20% * Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System * Severe aortic valve stenosis or regurgitation * Severe mitral stenosis * Severe right ventricular dysfunction or severe tricuspid valve disease * Evidence of intracardiac thrombus, vegetation, or mass * Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve * Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure * Myocardial infarction within 30 days prior to procedure * Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure * Active endocarditis, other ongoing infection requiring antibiotic therapy * Stroke or transient ischemic attack (TIA) within 30 days of procedure * Active peptic ulcer or active gastrointestinal bleeding * Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg * End-stage renal failure on dialysis * Life expectancy less than 1 year * Subject is on the waiting list for a heart transplant or has had a prior heart transplant * Pregnant (Participants of childbearing age are required to have a negative pregnancy test). * Known allergy to antiplatelet therapy, heparin, or to device materials * Inability to tolerate anticoagulation or antiplatelet therapies * Absence of appropriate venous access * Unable to have transesophageal echocardiography * Unwillingness to complete the required follow-up visits