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

Sponsor: Copenhagen University Hospital, Rigshospitalet • ClinicalTrials.gov ID: NCT07442357

Registry updated: 2026-10-05

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Description

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.

Interventions

Beta-lactam antibiotic with spectrum for Enterococcus faecalis (Drug)
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 (Drug)
Cephalosporin treatment

Eligibility criteria

Inclusion Criteria: * All patients \> 18 years of age undergoing TAVI at sites in Denmark Exclusion Criteria: * Patients who do not want to participate and have chosen to "opt-out" of the trial

Conditions

Aortic Valve Stenosis

Locations

Aalborg University Hospital — Aalborg, Denmark
Aarhus University Hospital — Aarhus, Denmark
Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark
Odense University Hospital — Odense, Denmark
Skåne University Hospital Lund — Lund, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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