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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aortic Valve Stenosis, Structural Valve Deterioration

Intervention / Treatment
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* Device: NVT ALLEGRA TAVI System TF
* Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NVT ALLEGRA System TF<br>NVT ALLEGRA System TF | Device: NVT ALLEGRA TAVI System TF<br>* 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<br>|
| Experimental: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM<br>EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM | Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM<br>* Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE). | Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with device success after the Valve In Valve (VIV) procedure | Device success after the VIV procedure to the VARC-3 criteria | 30 days | 
| Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure | Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure | 30 days | 
| Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention. | Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention. | 30 days | 
| Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria | 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. | 30 days | 
| Clinical efficacy at 1 year as defined by VARC-3 criteria | 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. | 1 year | 
| Trans-aortic mean gradient | Trans-aortic mean gradient 1 year after TAVR procedure | 1 year | 
| Death | Incidence of Death | 1 year | 
| Stroke | Incidence of Stroke | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valve-In-Valve, Aortic stenosis, Aortic regurgitation, Trans-catheter aortic valve, Degenerated aortic valve