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

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.

• NVT ALLEGRA TAVI System TF (Device): 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 (Device): Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

Primary outcomes

• Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE). [30 days]: Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).

Secondary outcomes

• Proportion of patients with device success after the Valve In Valve (VIV) procedure [30 days]: Device success after the VIV procedure to the VARC-3 criteria
• Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure [30 days]: Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure
• Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention. [30 days]: Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.
• Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria [30 days]: freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device.
• Clinical efficacy at 1 year as defined by VARC-3 criteria [1 year]: freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve related causes, KCCQ Overall Summary Score <45 or decline from baseline of >10 point.
• Trans-aortic mean gradient [1 year]: Trans-aortic mean gradient 1 year after TAVR procedure
• Death [1 year]: Incidence of Death
• Stroke [1 year]: Incidence of Stroke

Sex: All, ages: 18 Years to any

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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