Contemporary 1-Year Outcomes of Mitral Valve-in-Ring With Balloon-Expandable Aortic Transcatheter Valves in the U.S.
Mayra E Guerrero, Vinayak N Bapat, Paul Mahoney...
https://pubmed.ncbi.nlm.nih.gov/38599690Actively Recruiting
Led by American College of Cardiology · Updated on 2024-04-18
4000
Participants Needed
1
Research Sites
4 weeks
Total Duration
A
American College of Cardiology
Lead Sponsor
T
The Society of Thoracic Surgeons
Collaborating Sponsor
Researchers are evaluating the safety and real-world outcomes of the transcatheter mitral valve repair (TMVR) procedure through the TVT Registry. Developed by The Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), this registry supports a national surveillance system to track characteristics, treatments, and outcomes for patients receiving transcutaneous valve therapies. It aims to monitor quality of care and enable research based on collected data. The registry collects standardized patient-level data submitted by hospitals and healthcare providers. It provides confidential reports to participating centers to help improve care quality and serves as a data infrastructure for post-market studies. The focus is on transcatheter valve therapies, which are emerging treatments for mitral and aortic valve diseases, especially important as these conditions increase with aging populations. Participants' data include information on treatments, adverse events within 30 days, and long-term outcomes. The registry tracks patient safety, device performance, and treatment effectiveness. It addresses issues such as quality of life, independence, and treatment burdens for patients with severe valvular heart disease. Participation involves ongoing data collection with no direct treatment interventions, and the registry supports continuous monitoring and quality assessment.
CONDITIONS
STS/ACC TVT Registry Mitral Module
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies according to participant treatment
Participants receive a transcatheter valve therapy device called a Leaflet Clip as part of their clinical care.
1 procedure visit
Duration - Up to 10 years
Participants who undergo routine care are observed to assess device performance, safety, and clinical outcomes over time.
Periodic follow-up visits as per routine healthcare
Total: 1 location
1
American College of Cardiology
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
J
Joan K Michaels, RN
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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