Registry for tracking outcomes of mitral valve repair procedures
The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module
This study is tracking the results of mitral valve repair procedures to see how well they work and improve care for patients undergoing this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | American College of Cardiology Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT02245763 on ClinicalTrials.gov |
What this trial studies
The TVT Registry is a national surveillance system designed to monitor patient safety and real-world outcomes associated with transcatheter mitral valve repair (TMVR) procedures. It collects standardized data from participating hospitals to assess the quality of care for patients undergoing this treatment. The registry aims to provide confidential reports to healthcare providers to improve care quality and support research based on the collected data. Additionally, it serves as a scalable infrastructure for post-market studies of transcatheter valve therapies.
Who should consider this trial
Good fit: Ideal candidates for this registry include all patients undergoing transcatheter mitral valve repair procedures.
Not a fit: Patients who cannot tolerate anticoagulation or have active endocarditis or rheumatic mitral valve disease may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and effectiveness of mitral valve repair procedures, ultimately improving patient outcomes.
How similar studies have performed: Other national registries for transcatheter valve therapies have shown success in improving patient outcomes and safety monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia
- American College of Cardiology — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Joan K Michaels, RN
- Email: jmichael@acc.org
- Phone: 202-375-6309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.