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

NCT06049654 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis
  • Structural Valve Deterioration

Interventions

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

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049654 on ClinicalTrials.gov