What this study is
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's being tested
- TAVR
Intervention · DEVICE
subjects that underwent TAVR more than 3 years ago
- SAVR
Intervention · DEVICE
Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
Study details
- Sponsor
- Medstar Health Research Institute
- Conditions
- Aortic Valve Replacement
- Enrolling
- 100 people
- Starts
- 2018-02-20
- Est. completion
- 2028-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedTAVR subjects
You may qualify if
- A) TAVR performed more than 3 years ago
You can't join if
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate
- Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
- Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)
SAVR subjects
You may qualify if
- SAVR performed more than 3 years ago
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington Hospital Center
Washington D.C., District of Columbia, United States
- Megan Rowland · Contact202-877-2959megan.e.rowland@medstar.net
- Ron Waksman, MD · Principal investigator
Recruiting
Study team
Sponsor
Medstar Health Research Institute
Study ID TAVR Durability
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.