NCT06049654 Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
| NCT ID | NCT06049654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2024-02-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06049654 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06049654 currently recruiting?
Yes, NCT06049654 is actively recruiting participants. Contact the research team at raulmorenog@hotmail.com for enrollment information.
Where is the NCT06049654 trial being conducted?
This trial is being conducted at Alessandria, Italy, Brescia, Italy, Perugia, Italy, L'Hospitalet de Llobregat, Spain and 8 additional locations.
Who is sponsoring the NCT06049654 clinical trial?
NCT06049654 is sponsored by Fundación EPIC. The trial plans to enroll 104 participants.