Capstan Medical TMVR Study: FIH

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

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.

Key facts

Study ID: NCT06600191
Run by: Capstan Medical
People needed: 10
Starts: 2025-02-24
Expected to finish: 2031-12-01
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

Pontificia Universidad Católica de Chile — Santiago, Chile (enrolling)
Auckland City Hospital — Auckland, New Zealand (enrolling)
Monash Health, Victorian Heart Hospital — Melbourne, Australia

Full record on ClinicalTrials.gov

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