Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Purpose
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.
Condition
- Aortic Valve Replacement
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
for TAVR subjects a) TAVR performed more than 3 years ago
Exclusion Criteria
- 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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute
Detailed Description
There is limited available information on long term TAVR valve function. 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. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.