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Clinical Trials in Denmark / NCT07442357
Recruiting Not applicable

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

NCT07442357 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2026-10-01
Last updated
2026-10-05

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Beta-lactam antibiotic with spectrum for Enterococcus faecalisCephalosporin

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of patients with a composite outcome of bacteremia or death by 6 months. — 6 months post-TAVI
    Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI. Death is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI.

Trial sites (5)

FacilityCityRegionStatus
Aalborg University Hospital Aalborg Denmark Recruiting
Aarhus University Hospital Aarhus Denmark Recruiting
Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark Recruiting
Odense University Hospital Odense Denmark Recruiting
Skåne University Hospital Lund Lund Sweden Not Yet Recruiting

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock Recruiting
Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer Recruiting
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Prospective Surveillance for Breast Cancer-Related Lymphedema Active, not recruiting
Long-term Systematic Follow-up of Patients With Klinefelter Syndrome Followed at the Department of Growth and Reproduction, Rigshospitalet Enrolling by invitation

Other trials for the same condition

The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI) Recruiting
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Active, not recruiting
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis Active, not recruiting
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07442357 on ClinicalTrials.gov ↗ ← All trials in Denmark