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The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
Sponsor: Rigshospitalet, Denmark
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1986
Start Date
2026-06-01
Completion Date
2029-06-01
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Beta-lactam antibiotic with spectrum for Enterococcus faecalis
Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI
Cephalosporin
Cephalosporin treatment
Locations (1)
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark