Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Recruiting
N/A
Interventional Study
Aortic Valve Stenosis
Structural Valve Deterioration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 104 (estimated)
- Sponsor
- Fundación EPIC · Other
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About This Trial
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patients meeting ALL the following criteria will be included:
* Patients aged ≥ 18 years.
* Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve …
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