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

RecruitingNAAges 18 Years - anyAllFundación EPIC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

  • NVT ALLEGRA TAVI System TF
  • EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
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Where

12 sites
Azienda Ospedaliero- Universitaria di Alessandria
Alessandria, Italy
ASST Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario de La Paz
Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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