Capstan Medical TMVR Study: FIH

Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System

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