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Clinical Trials in Italy / NCT06049654
Recruiting Not applicable

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

NCT06049654 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-02-01
Last updated
2026-09-24

Condition(s) studied

Aortic Valve StenosisStructural Valve Deterioration

Investigational drug(s) / intervention(s)

NVT ALLEGRA TAVI System TFEDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

NVT ALLEGRA TAVI System TF: 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

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM: Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: 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).

Primary outcome measure(s)

Trial sites (12)

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

More Fundación EPIC trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06049654 on ClinicalTrials.gov ↗ ← All trials in Italy