The ReTAVI Prospective Observational Registry
Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry
Institut für Pharmakologie und Präventive Medizin
250 participants
Sep 5, 2023
OBSERVATIONAL
Conditions
Summary
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- 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, 3 years and 5 years.
Eligibility
Inclusion Criteria7
- Consecutive patients fulfilling the following criteria:
- Consenting adult patient (≥18 years)
- Procedural success of the first TAVI
- TAVI device failure of the index THV, irrespective of SVD severity
- Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
- The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
- Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)
Exclusion Criteria4
- Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
- Life expectancy below 12 months
- Patients with largely incomplete data with respect to the aims of the project
- Pregnant women at the time of the redo-TAVI
Interventions
Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)
Locations(62)
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NCT05601453