VIVALL 2 study
Research type
Research Study
Full title
Randomized Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
IRAS ID
335531
Contact name
Mohammad ALKHALIL
Contact email
Sponsor organisation
Fundacion Epic
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
The study will enroll patients that had previously had a biological aortic valve implanted which has now degenerated. The main limitation of surgically implanted biological aortic valves is valve degeneration, that may lead to recurrence of symptoms and the need for a valve reintervention. Currently, the most frequent treatment of symptomatic severe haemodynamic deterioration of a biological aortic valve is transcatheter aortic valve replacement (TAVR) in most centers. In fact, degenerated surgically implanted biological aortic valves comprise about 5% of patients currently undergoing TAVR (the so-called valve-in-valve (VIV) procedure).
One of the main limitations of VIV procedures is the higher post-procedural gradients in comparison with those observed when treating native aortic valve stenosis, and this may have an impact on mortality.The main objective of this study is to compare the haemodynamic results between the self-expandable Allegra THV and the balloon-expandable Sapien 3 or Sapien Ultra THV in patients with degenerated biological aortic valves implanted surgically that are referred to a transcatheter VIV procedure.
REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0428
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion