Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06600191

Capstan Medical TMVR Study: FIH

Sponsor: Capstan Medical

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-24

Completion Date

2030-12

Last Updated

2025-04-04

Healthy Volunteers

Conditions

Mitral Regurgitation

Interventions

DEVICE

Capstan System transcatheter mitral valve replacement

This is a first human use trial exploring a novel transcatheter mitral valve replacement implant and electro-mechanical delivery system. The device offers a minimally invasive repair for patients who have at symptomatic regurgitation who are otherwise ineligable for surgical intervention, or who have no other prospects for treatment and in whom medical therapy has already been optimised.

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

Locations (3)

Monash Health, Victorian Heart Hospital

Melbourne, Australia

Pontificia Universidad Católica de Chile

Santiago, Chile

Auckland City Hospital

Auckland, New Zealand