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

Sponsor

Fundación EPIC (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06049654

Collaborator

(none)

104

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Structural Valve Deterioration	Device: NVT ALLEGRA TAVI System TF Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: NVT ALLEGRA System TF

NVT ALLEGRA System TF

Device: NVT ALLEGRA TAVI System TF

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

Experimental: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).