NCT06600191

Capstan Medical TMVR Study: FIH

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Capstan Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-12-01
• Completion: 2030-12-01
• First posted: 2024-09-19
• Last updated: 2025-04-04

Locations

3 sites across 3 countries: Australia, Chile, New Zealand