Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT06049654
- Record updated
- 24 September 2026
- Original description
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.Read full original descriptionShow less
Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
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.
Inclusion: 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 regurgitation; The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease; Heart team decision of VIV procedure; Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.
Exclusion: Presence or suspicious of biological aortic valve thrombosis; Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated; Patients whose life expectancy is < 1 year due to non-cardiac comorbid conditions; Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams; Female patients in gestational age; Patients meeting, at least, 1 of the following criteria will be excluded:; Patients who openly express their refusal to participate in the study; Ongoing sepsis and/or suspicious or diagnosis of endocarditis; True inner diameter of the prosthetic valve > 27 mm; Transfemoral access inadequate to accommodate an 18F sheath; Patients included in other clinical trials (excluding registries).