Clinical Trial: STS/ACC TVT Registry Mitral Module
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: The Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapies Registry Mitral Module
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 and replacement (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.
Detailed Summary:
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry.
The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post market studies.
Background and Significance
Transcatheter valve therapies are now emerging into clinical practice from the research phase in the United States. An Expert Consensus Document on Transcatheter Valve Therapy has outlined the initial technology, targeted patient population, and the multidisciplinary heart team and specialized facilities needed. The document also proposes the establishment of a national registry of patients with valvular heart disease that can collect and analyze data as these new valve treatment options become available. Surveillance of device performance, monitoring of long-term outcomes, and performance of comparative effectiveness research are some of the proposed uses of the registry.
Transcatheter valve therapies have emerged because of unmet
Sponsor: American College of Cardiology
Current Primary Outcome: Number of Patients with Adverse Events [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: American College of Cardiology
Dates:
Date Received: September 2, 2014
Date Started: November 2013
Date Completion:
Last Updated: September 19, 2014
Last Verified: September 2014
