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Life sciences · Observational Study
ClinicalTrials.gov · October 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05601453). This is a study registration, not published results. Lead sponsor: Institut für Pharmakologie und Präventive Medizin. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure. Interventions: PROCEDURE: Elective redo transcatheter aortic valve implantation (redo-TAVI). Primary outcome measures: Efficacy: VARC-3 defined device success at 30 days , 30 days; Technical success: Technical success (at exit from procedure room) , end of intervention; Safety: VARC-3 defined early safety at 30 days , 30 days; Procedural Outcomes (30 days) , 30 days; Durability of the second aortic THV (30 days) , 30 days; Durability of the second aortic THV (3 months) , 3 months; Durability of the second aortic THV (12 months) , 12 months; Durability of the second aortic THV (3 years) , 3 years; Durability of the second aortic THV (5 years) , 5 years. Brief 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.