National Registry Tracking Safety and Outcomes of Mitral Valve Repair Using the Leaflet Clip Device
Led by American College of Cardiology · Updated on 2026-06-15
4000
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
The TVT Registry Mitral Module is a national surveillance study designed to monitor patient safety and outcomes related to the transcatheter mitral valve repair TMVR procedure. This registry collects standardized data from participating hospitals to assess the quality of care and supports research on this emerging treatment for mitral valve disease. It addresses the increasing need for treatments as degenerative heart valve diseases become more common with aging populations.
Participants in this registry have undergone or are undergoing TMVR procedures using devices like the Leaflet Clip. Data is submitted by hospitals to The Society of Thoracic Surgeons and the American College of Cardiology to evaluate treatment characteristics and outcomes. The registry also serves as a platform for post-market studies, tracking device performance and long-term results.
During the study, patients health outcomes such as adverse events within 30 days after the procedure are monitored. The registry provides periodic confidential reports to hospitals to help improve care quality. Participants data contribute to research assessing treatment safety, effectiveness, and patient quality of life over time, with follow-up continuing through 2030.
CONDITIONS
Brief Title
STS/ACC TVT Registry Mitral Module
Research Team
J
Joan K Michaels, RN
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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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States: Data From the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry.