Actively Recruiting
Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Led by Medstar Health Research Institute · Updated on 2023-05-26
100
Participants Needed
1
Research Sites
514 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- TAVR performed more than 3 years ago
- SAVR performed more than 3 years ago
- SAVR subjects matched to an enrolled TAVR subject
- Ability to consent to participate or have a legally authorized representative consent
You will not qualify if you...
- Unable to consent to participate without a legally authorized representative
- Unwilling to participate
- Re-intervention to prosthetic aortic valve since TAVR or SAVR procedure (e.g., balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
- Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR or post-SAVR (mean aortic gradient ≥20 mmHg and/or moderate to severe transvalvular aortic regurgitation)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
M
Megan Rowland, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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