NCT06049654

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Valve Stenosis
• Structural Valve Deterioration

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-09-22
• Last updated: 2025-12-19

Locations

9 sites across 2 countries: Spain, United Kingdom