ClinicaliQ Trial Snapshot
- Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT06049654.
- What is being tested: Direct comparison of two transcatheter aortic valve (TAVI) systems—the self-expandable supra-annular Allegra valve versus the balloon-expandable intra-annular Edwards Sapien valve—in patients requiring valve-in-valve procedures for degenerated surgical bioprostheses.
- Patient eligibility overview: The trial includes patients with failed or degenerating biological aortic surgical valves who are candidates for transcatheter valve replacement, representing a growing clinical population as first-generation surgical bioprostheses reach end-of-life.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.