The Re-TAVI Registry
Research type
Research Study
Full title
The Re-TAVI Prospective Observational Registry - Evaluation of Clinical Outcomes of Patients Undergoing a redo-TAVI procedure; a Multicentre Prospective Observational Registry
IRAS ID
327366
Contact name
Vasileios Panoulas
Contact email
Sponsor organisation
IPPMed GmbH
Clinicaltrials.gov Identifier
NCT05601453, ClinicalTrials.gov
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
The Re-TAVI Registry is an investigator-initiated, non-interventional (observational), multicenter, international prospective registry in patients undergoing redo-TAVI, aiming to include an estimated number of 150 patients in 50 hospitals performing heart valve surgery.
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) live long enough to experience structural valve deterioration and may develop an indication for redo-TAVI.
However, the evidence on redo-TAVI (where a transcatheter heart valve (THV) is implanted into another THV) is limited, with initial data showing acceptable safety and efficacy in a highly selected population.As this research question is not addressed by current registries or studies it is timely to set up a prospective observational study in which key procedural parameters and long-term outcomes will be documented. Further, data on short-and long-term hemodynamic performance of redo-TAVI procedures will be collected improving the registry’s value to demonstrate the clinical benefits of the procedure. Currently, SAPIEN 3 / Ultra THVs are the only registered medical devices for Redo-TAVI use.
We aim to collect pre-, peri-, postoperative and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year. The purpose of this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing redo-TAVI procedures.
Generally, consenting adult patients undergoing a redo-TAVI procedure with a Sapien 3 / 3 Ultra transcatheter aortic heart valve are potentially eligible to participate in the registry. Due to the observational character, there will be no additional obligations to the patient besides the standard of care treatment they receive.
REC name
Wales REC 4
REC reference
23/WA/0191
Date of REC Opinion
18 Jul 2023
REC opinion
Further Information Favourable Opinion