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Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
RecruitingObservational study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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)
About the study
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.
What is being tested
- TAVR (device)
- SAVR (device)
Sponsor: Medstar Health Research Institute · Participants: 100 · Started: Feb 20, 2018
Contact the study team
- Megan Rowland, MPH · Phone: 202-877-2959
Official record on ClinicalTrials.gov — NCT03002272
Locations in the U.S.
| District of Columbia | Washington Hospital Center, Washington D.C. |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.