PORTICO Valve in Valve study
Research type
Research Study
Full title
Assessment of the Portico™ Transcatheter Aortic Valve for Valve-in-Valve Use
IRAS ID
300239
Contact name
Michael Mullen
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 30 days
Research summary
Research Summary
This is an observational study to collect retrospective data on PorticoTM Valve-in-Valve (ViV) usage. It is data-collection only.The objective of this study is to evaluate the safety and performance of the PorticoTM transcatheter aortic valve in the treatment of a failed surgical aortic valve prosthesis ViV.
Summary of results
The objective of this data-collection study was to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.The available study results demonstrate that the safety and performance profile of the Portico valve when used for Valve-in-Valve (ViV) treatment is consistent with contemporary devices at 1 year post TAVI.
The rate of all-cause mortality at 1-year was numerically lower in the Portico Retrospective VIV Registry than other devices approved for VIV use, aortic valve area was the same or greater, and mean aortic gradients were numerically lower.
Although the Portico valve will not be further investigated for VIV use, results from this registry suggest the Navitor TAVI system, which shares many similarities to Portico, warrants further investigation as an option for VIV TAVI.
REC name
London - Bromley Research Ethics Committee
REC reference
21/LO/0623
Date of REC Opinion
12 Oct 2021
REC opinion
Further Information Favourable Opinion