Status:

NOT_YET_RECRUITING

Antimicrobial Strategy for Device Implantation

Lead Sponsor:

University of Calabria

Conditions:

CIED-related Infections

Eligibility:

All Genders

18+ years

Brief Summary

Infections associated with cardiovascular implantable electronic devices (CIEDs) represent one of the major postoperative complications in interventional cardiology. These infections-including lead-re...

Eligibility Criteria

Inclusion

  • Age ≥ 18 years
  • Clinical indication for CIED implantation or generator replacement
  • Signed informed consent to participate in the study

Exclusion

  • Known allergy to taurolidine or any of the excipients
  • Severe immunodeficiency status (e.g., patients undergoing chemotherapy, with AIDS, or immunosuppressed following organ transplantation)
  • Life expectancy \< 12 months due to severe comorbidities (e.g., metastatic cancer, end-stage organ failure)
  • Pregnant or breastfeeding women

Key Trial Info

Start Date :

September 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT07158502

Start Date

September 1 2025

End Date

December 31 2027

Last Update

September 5 2025

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Antimicrobial Strategy for Device Implantation | DecenTrialz