Clinical Trial: STS/ACC Transcatheter Valve Therapy Registry (TVT Registry)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry).

Brief Summary: The TVT Registry™ is a benchmarking tool developed to track patient safety and real-world outcomes related to the transcatheter aortic valve replacement (TAVR) 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 aortic stenosis.

Detailed Summary:

Purpose of the Registry

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. The first of several approaches to replacing the aortic valve without open-chest surgery has now become a reality. Other valve and delivery systems are expected to be approved in the upcoming years. 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. Surveill
Sponsor: The Society of Thoracic Surgeons

Current Primary Outcome: Major adverse cardiac and cerebrovascular events [ Time Frame: 30 day ]

increase in the 30-day risk of adverse events among patients receiving TAVR


Original Primary Outcome: Same as current

Current Secondary Outcome: Mortality [ Time Frame: 1 year ]

Proportion of patients who are alive with at least moderate functional improvement (defined as at least 10 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline) at 1 year after receiving TAVR


Original Secondary Outcome: Same as current

Information By: The Society of Thoracic Surgeons

Dates:
Date Received: November 14, 2012
Date Started: June 2012
Date Completion: June 2022
Last Updated: April 19, 2016
Last Verified: April 2016