Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NVT ALLEGRA TAVI System TF
- EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
Treatment groups
104 Participants
are divided into 2 treatment groupsLocations
11Italy
Azienda Ospedaliero- Universitaria di Alessandria Alessandria Italy
Azienda Ospedaliera di Perugia Perugia Italy
Spain
Hospital Universitari de Bellvitge08907, L'Hospitalet de Llobregat Spain
Hospital Clinico San Carlos28040, Madrid Spain
Sponsors and collaborators
Fundación EPIC
Lead sponsor
Source ClinicalTrials.gov