REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Recruiting
Observational Study
Aortic Stenosis
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.
At a Glance
- Age
- 18 – 105
- Sex
- Any
- Study type
- Observational
- Participants needed
- 225 (estimated)
- Sponsor
- Medtronic Cardiovascular · Industry
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About This Trial
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR
Exclusion Criteria:
* BVF due solely to paravalvular regurgitation
* Active endocarditis
* Untreated acute valve thrombosis
* Life-expectancy less than 1-year
* Subject is less than legal age of consent, legally …
Contacts