Recruiting

Transcatheter Aortic Prosthesis

Sponsor:

Medstar Health Research Institute

Code:

NCT03002272

Conditions

Aortic Valve Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAVR

SAVR

Study Details

Brief summary:

In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.

Conditions

Aortic Valve Replacement

Study ID

NCT03002272

Start date

Feb 20, 2018

Status verified date

May, 2023

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria for TAVR subjects

a) TAVR performed more than 3 years ago

Exclusion criteria

1. Subjects unable to consent to participate, unless the subject has a legally authorized representative
2. Subjects unwilling to participate
3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Inclusion criteria for SAVR subjects

1. SAVR performed more than 3 years ago
2. Propensity matched to an enrolled TAVR subject

Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

TAVR

This observational study will enroll subjects that underwent TAVR more than 3 years ago.

SAVR

Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Interventions

TAVR

subjects that underwent TAVR more than 3 years ago

SAVR

Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Primary outcome measure

  • Prosthetic valve dysfunction [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

Megan Rowland, MPH

202-877-2959megan.e.rowland@medstar.net

Locations

Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Megan Rowland

202-877-2959megan.e.rowland@medstar.net

Principal Investigator:

Ron Waksman, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

May 26, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2023-05-26.