NCT04167579

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Hoag Memorial Hospital Presbyterian · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Transcutaneous Valve Therapies

Interventions

Type	Name	Description
DEVICE	Transcutaneous Valve Therapy	Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.

Timeline

• Start date: 2019-05-20
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2019-11-19
• Last updated: 2023-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study