Actively Recruiting

Age: 1Year +
All Genders
Healthy Volunteers
ID02245763

The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module

Led by American College of Cardiology · Updated on 2024-04-18

4000

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

American College of Cardiology

Lead Sponsor

T

The Society of Thoracic Surgeons

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

STS/ACC TVT Registry Mitral Module

Who Can Participate

Age: 1Year +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

American College of Cardiology

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

Actively Recruiting

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Research Team

J

Joan K Michaels, RN

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

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/38599690

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.

Mayra Guerrero, Sreekanth Vemulapalli, Qun Xiang...

https://pubmed.ncbi.nlm.nih.gov/32138529