Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
Recruiting
Observational Study
Aortic Valve Replacement
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
Medstar Health Research Institute · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 aort…
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)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.