Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Fundación EPIC
- Azonosító
- NCT06049654
- A regiszteradat frissítve
- 2026. szeptember 24.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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).