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

NCT07442357 | Not Yet Recruiting DMC

• 1 other identifier: p-2025-19665
• Study Type: interventional
• Target: 1,986
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis; Aortic Valve Replacement; Transcatheter Aortic Valve Replacement; Aortic Valve; Cephalosporin; Ampicllin; Bacteremia; Per Procedure Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Number of patients with a composite outcome of bacteremia or death by 6 months.

  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.

  6 months post-TAVI

Secondary Outcomes (5)

• Number of patients who died by 6 months

  6 months post-TAVI

• Bacteremia assessed by collection of blood cultures.

  6 months post-TAVI

• Number of patients with acute kidney failure assessed by plasma creatinine levels.

  6 months post-TAVI

• Length of hospital stay

  From the day of TAVI-procedure until the day of discharge after the TAVI-procedure e.g. days from TAVI-procedure until discharge assessed up to 6 months post-TAVI due to end of follow-up.

• Days-out-of-hospital from TAVI to 6 months

  6 months post-TAVI

Study Arms (2)

Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis

ACTIVE COMPARATOR

Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis

Drug: Beta-lactam antibiotic with spectrum for Enterococcus faecalis; Drug: Cephalosporin

Cephalosporin (1st, 2nd, 3rd generation)

ACTIVE COMPARATOR

Cephalosporin (1st, 2nd, 3rd generation)

Drug: Cephalosporin

Interventions

Cephalosporin DRUG

Cephalosporin treatment

Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis; Cephalosporin (1st, 2nd, 3rd generation)

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 (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \> 18 years of age undergoing TAVI at sites in Denmark

You may not qualify if:

• Patients who do not want to participate and have chosen to "opt-out" of the trial

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Bacteremia

Interventions

Monobactams; Cephalosporins

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazines

Central Study Contacts

Emil L Fosbøl, MD, PhD

CONTACT

+ 45 35 45 63 40; emil.fosboel@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Prospective, crossover, cluster-randomized study

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)