Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06600191

Capstan Medical TMVR Study: FIH

Led by Capstan Medical · Updated on 2025-04-04

10

Participants Needed

3

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Capstan Medical TMVR Study: FIH

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63; 18 years at the time of consent
  • Moderate-severe (3+) or severe (4+) mitral regurgitation
  • NYHA II or greater symptoms despite optimal medical treatment
  • Local heart team agrees TMVR is preferred over surgery or other treatments
  • Ability and willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction (LVEF) less than 20%
  • Anatomic features unsuitable for the Capstan System (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC)
  • Severe aortic valve stenosis or regurgitation
  • Severe mitral stenosis
  • Severe right ventricular dysfunction or severe tricuspid valve disease
  • Intracardiac thrombus, vegetation, or mass
  • Prior mitral valve intervention interfering with valve placement
  • Percutaneous coronary, carotid, or other endovascular intervention within 30 days prior
  • Myocardial infarction within 30 days prior
  • Cardiac resynchronization therapy (CRT) device implanted within 30 days prior
  • Active endocarditis or ongoing infection requiring antibiotics
  • Stroke or transient ischemic attack (TIA) within 30 days prior
  • Active peptic ulcer or gastrointestinal bleeding
  • Severe pulmonary arterial hypertension with fixed PASP >85 mmHg
  • End-stage renal failure on dialysis
  • Life expectancy less than 1 year
  • On waiting list for or prior heart transplant
  • Pregnant
  • Known allergy to antiplatelet therapy, heparin, or device materials
  • Cannot tolerate anticoagulation or antiplatelet therapies
  • No appropriate venous access
  • Unable to have transesophageal echocardiography
  • Unwilling to complete follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Monash Health, Victorian Heart Hospital

Melbourne, Australia

Not Yet Recruiting

2

Pontificia Universidad Católica de Chile

Santiago, Chile

Actively Recruiting

3

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

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Research Team

D

David Ligon, MSE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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