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

Fundación EPIC

Status: Enrolling

Conditions: Aortic Valve Stenosis; Structural Valve Deterioration

Treatments: Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM; Device: NVT ALLEGRA TAVI System TF

Study type: Interventional

Funder types: Other

Identifiers

NCT06049654

EPIC34-VIVALL 2 TRIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 2 patient groups

NVT ALLEGRA System TF

Active Comparator group

Description:

NVT ALLEGRA System TF

Treatment:

Device: NVT ALLEGRA TAVI System TF

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Experimental group

Description:

EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Treatment:

Device: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM