Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Recruiting now · Not applicable

Conditions studied: Aortic Valve Stenosis, Structural Valve Deterioration

In brief

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.

Key facts

Study ID

NCT06049654

Run by

Fundación EPIC

People needed

104

Starts

2024-02-01

Expected to finish

2027-11-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Azienda Ospedaliero- Universitaria di Alessandria — Alessandria, Italy (enrolling)
• Azienda Ospedaliera di Perugia — Perugia, Italy (enrolling)
• Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Spain (enrolling)
• Hospital Clinico San Carlos — Madrid, Spain (enrolling)
• Hospital Universitario de La Paz — Madrid, Spain (enrolling)
• Hospital Universitario Puerta De Hierro — Majadahonda, Spain (enrolling)
• Hospital Clínico Universitario de Salamanca — Salamanca, Spain (enrolling)
• Hospital Universitari I Politècnic de La Fe — Valencia, Spain (enrolling)
• Manchester University NHS Foundation Trust — Manchester, United Kingdom (enrolling)
• Freeman Hospital — Newcastle, United Kingdom (enrolling)
• Morriston Hospital, Swansea — Swansea, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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