Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Fundación EPIC
104 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria11
- Patients meeting, at least, 1 of the following criteria will be excluded:
- Patients who openly express their refusal to participate in the study.
- Female patients in gestational age.
- 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.
- Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
- 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.
- 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).
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Interventions
Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06049654