Capstan TMVR System for Mitral Regurgitation

Not yet recruiting at 2 trial locations
CH
CE
Overseen ByCourtney Elliott
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Capstan Medical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This early feasibility study is evaluating the safety and performance of the Capstan Compass Robotic System™ for transcatheter mitral valve replacement in patients with symptomatic, moderate-to-severe or severe mitral regurgitation who are unsuitable for surgical repair or transcatheter edge-to-edge repair.

Are You a Good Fit for This Trial?

This trial is for people with moderate-to-severe or severe mitral regurgitation (a leaky heart valve) who have symptoms and cannot have standard surgical repair or other less invasive procedures.

Inclusion Criteria

Local multi-disciplinary heart team deems heart failure management optimized based on participant characteristics and applicable guidelines
Ability and willingness to provide written informed consent prior to any study related procedure(s)
I am at higher, but not extreme, risk for mitral valve surgery according to my heart team.
See 5 more

Exclusion Criteria

I have severe heart problems that cannot be treated.
I have a blood clot or mass inside my heart.
I have had a heart attack in the last 30 days.
See 26 more

What Are the Treatments Tested in This Trial?

Interventions

  • Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement

Trial Overview

The study is testing the Capstan Compass Robotic System, a new robotic device used to replace the mitral valve through a minimally invasive procedure. The main goal is to see if it works safely in these patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TMVRExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Capstan Medical

Lead Sponsor

Trials
1
Recruited
10+