STS & ACC Foundation's Transcutaneous Valve Therapy (TVT) Registry Foundation's Transcutaneous Valve Therapy (TVT) Registry

Recruiting

• Conditions: Transcutaneous Valve Therapies

• Registration Number: NCT04167579
• Lead Sponsor: Hoag Memorial Hospital Presbyterian

Brief 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.

Detailed Description

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 forpost market studies.

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events	30 days from procedure	increase in the 30-day risk of adverse events among patients receiving TAVR

Secondary Outcome Measures

Name	Time	Method
Mortality	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
Major adverse cardiac and cerebrovascular events	1 year from procedure	increase in the 1 year risk of adverse events among patients receiving TAVR

Trial Locations

Locations (1)

Hoah Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States