Recruiting

TAVR

Sponsor:

The Society of Thoracic Surgeons

Code:

NCT01737528

Conditions

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Aortic Valve Replacement

Study Details

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.

Conditions

Aortic Valve Stenosis

Study ID

NCT01737528

Start date

Jun, 2012

Status verified date

Nov, 2021

Completion date

Jun, 2035

Anticipated

Primary completion date

Jun, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 18 years or older

Study Design

Enrollment

16000 participants

Anticipated

Interventions and Outcome Measures

Arms

TAVR Patients

Will include all patients 18 years or over who undergo Transcatheter Aortic Valve Replacement (TAVR) for severe aortic stenosis. The sample size will include all patients entered into the Registry.

Interventions

Transcatheter Aortic Valve Replacement

Minimal invasive implantation of a biological prothesis in Aortic Position

Primary outcome measure

  • Major adverse cardiac and cerebrovascular events [ Time Frame: 30 day ]

Central Contacts and Locations

Central contacts

Joan Michaels

(202) 375 6309jmichael@acc.org

Locations

American College of Cardiology

Recruiting

Washington, District of Columbia, United States, 20037

Contacts

Joan Michaels

202-375-6309jmichael@acc.org

More Information

Sponsor

The Society of Thoracic Surgeons

Last update posted

Aug 25, 2022

Last verified

Nov, 2021

Keywords

  • severe symptomatic native aortic valve stenosis
  • inoperable or high risk for open aortic valve replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Society of Thoracic Surgeons on 2022-08-25.