Recruiting

Observational Study

Sponsor:

American College of Cardiology

Code:

NCT02245763

Conditions

Mitral Valve Regurgitation

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Accepted

Interventions

Leaflet Clip

Study Details

Brief summary:

The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter mitral valve repair (TMVR) procedure. Created by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of mitral valve disease.

Conditions

Mitral Valve Regurgitation

Study ID

NCT02245763

Start date

Nov, 2013

Status verified date

Mar, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All patients

Exclusion Criteria:

  • 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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Leaflet Clip

Primary outcome measure

  • Number of Patients with Adverse Events [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Joan K Michaels, RN

202-375-6309jmichael@acc.org

Locations

American College of Cardiology

Recruiting

Washington D.C., District of Columbia, United States, 20037

More Information

Sponsor

American College of Cardiology

Last update posted

Jun 15, 2026

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by American College of Cardiology on 2026-06-15.