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.
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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 …
Contacts

RAÚL MORENO GÓMEZ, MD, PhD

0034917277000

raulmorenog@hotmail.com

CONTACT

FUNDACION EPIC

0034987876135

iepic@fundacionepic.org

CONTACT