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

The Society of Thoracic Surgeons and American College of Cardiology Foundation's Transcutaneous Valve Therapy (TVT) 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.

Study Overview

• Status: Recruiting
• Conditions: Transcutaneous Valve Therapies
• Intervention / Treatment: Device: Transcutaneous Valve Therapy

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Colleen Balius; Phone Number: 9497641497; Email: colleen.balius@hoag.org

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Hoah Memorial Hospital Presbyterian
      • Contact: Colleen Balius, BSN, RN; Phone Number: 949-764-1497; Email: colleen.balius@hoag.org
      • Principal Investigator: Colleen Balius, BSN, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebrovascular events	increase in the 30-day risk of adverse events among patients receiving TAVR	30 days from procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	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	1 year
Major adverse cardiac and cerebrovascular events	increase in the 1 year risk of adverse events among patients receiving TAVR	1 year from procedure

Collaborators and Investigators

• Sponsor: Hoag Memorial Hospital Presbyterian

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Anticipated): May 20, 2025
• Study Completion (Anticipated): May 20, 2025

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 172-19-CV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No