RESOUND-EU Registry
Research type
Research Study
Full title
SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry -
IRAS ID
360125
Contact name
Sagar Doshi
Contact email
Sponsor organisation
IPPMed GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 6 months, 30 days
Research summary
Transcatheter aortic valve replacement (TAVI) is now the main treatment for older patients at moderate to high risk who have severe aortic valve narrowing and symptoms. Thanks to successful studies involving low-risk patients, TAVI is now also being used more often in younger patients in their 60s and 70s who don't have many other health problems.
Many of these younger patients are expected to live more than 5 years after the procedure, and many may live more than 10 years. Because of this, how long the replacement valve lasts (its durability) has become a major concern.
So far, fewer than 10% of TAVI valves have completely failed after 8–10 years. However, some studies show that early signs of wear and tear on the valve can be seen in about one-third of patients after 8 years. These early changes could be the first step toward full valve failure and symptoms, which may develop later in many of these patients.
This prospective study will look at how patients do and how well the SAPIEN 3 Ultra RESILIA valve performs over a 10-year period.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
26/EE/0036
Date of REC Opinion
20 Feb 2026
REC opinion
Favourable Opinion