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Recruiting
NCT07442357
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
Conditions: Aortic Valve Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1986
Sponsor: Copenhagen University Hospital, Rigshospitalet
Location: Aalborg University Hospital Aalborg
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.
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
Source: ClinicalTrials.gov (NCT07442357). StuddyBuddy aggregates publicly available trial information.