drugset / Trial / NCT07442357
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ampicillin | Unknown | 2 g | Intravenous |