Observational Study of Leaflet Clip for Mitral Valve Regurgitation

This is an observational study, meaning researchers are gathering information about how a procedure called Leaflet Clip works in real-world settings for people with mitral valve regurgitation (a condition where the heart's mitral valve doesn't close tightly, causing blood to leak backward). The study aims to track the safety and effectiveness of this procedure. You might be able to join if you have mitral valve regurgitation, are at least 1 year old, and can tolerate certain medications for the procedure. The main goal is to see how many patients experience adverse events (unwanted side effects or complications) within 30 days after the procedure. The study is currently collecting data from many hospitals across the country.

Study design
This is an observational study involving about 4000 participants. It tracks patient information from hospitals that perform the Leaflet Clip procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for at least 30 days after the procedure to track adverse events.

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NCT02245763

STS/ACC TVT Registry Mitral Module

Recruiting
Not specifiedAges 1+Observational
American College of Cardiology
~4,000 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Leaflet Clip

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients with Adverse Events
Measured over 30 days
Mitral Valve Regurgitation
1 sites across 1 states
District of Columbia1

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Eligibility criteria

Inclusion

All patients

Exclusion

Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
Active endocarditis of the mitral valve
Rheumatic mitral valve disease
Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
  • Number of Patients with Adverse Events30 days