Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
Recruiting
N/A
Interventional Study
Aortic Valve Stenosis
Bicuspid Aortic Valve
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- Cedars-Sinai Medical Center · Other
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About This Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review.
The purpose o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged \> 50 years of age
* Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
* …
Contacts