drugset / Trial / NCT07442357

The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial

NCT07442357

Not yet recruiting 1986 enrolled Rigshospitalet, Denmark
RandomizedCrossoverOpen-labelPrevention

Summary

The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI). The study tests whether cephalosporin plus beta-lactam antibiotic with spectrum for Enterococcus faecalis as per procedural prophylaxis is superior to cephalosporin alone in reducing the composite outcome of bacteremia or death at 6 months post-TAVI.

Timeline

Start
2026-06-01
Primary completion
2029-06-01
Completion
2029-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ampicillin Unknown 2 g Intravenous

Indications