RecruitingNot ApplicableNCT06600191

Capstan Medical TMVR Study: FIH

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

Sponsor

Capstan Medical

Enrollment

10 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Mitral Regurgitation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Capstan System transcatheter mitral valve replacement for people with mitral regurgitation. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECapstan 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.