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

Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

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.

In the VIVALL.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular Allegra or the balloon-expandable intra-annular Edwards systems. The primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. The proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. Different countries will participate in the study.

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).