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NCT Number: NCT07158502

Antimicrobial Strategy for Device Implantation

Infections associated with cardiovascular implantable electronic devices (CIEDs) represent one of the major postoperative complications in interventional cardiology. These infections-including lead-related endocarditis, subcutaneous pocket infections, and sepsis-are characterized by high rates of morbidity, mortality, and healthcare costs. According to current epidemiological data, the incidence of CIED-related infections is estimated to be around 0.5-2% within the first 12 months and may rise to 5% over long-term follow-up. These infections are associated with a mortality rate of up to 34% and often require device explantation and prolonged antibiotic therapy.

TauroPace™ is an antimicrobial solution based on taurolidine, a broad-spectrum, non-antibiotic agent that acts by disrupting bacterial biofilms and preventing microbial colonization. Taurolidine has a favorable safety profile, does not induce antibiotic resistance, and is already approved in Europe as a CE-marked medical device (Directive 93/42/EEC). The application of TauroPace™ to the surface of CIEDs prior to implantation may significantly reduce the incidence of infections compared to the current standard, which consists of irrigating the device pocket with sterile saline solution.

The aim of this study is to rigorously and systematically evaluate the effectiveness of TauroPace™ compared to standard clinical practice.

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Key information

Conditions

CIED-related Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

TauroPace Cohort

Drug

After sterile opening of the vial, the entire content of TauroPace™ will be poured into single-use sterile trays. Following skin incision, the surgical site will be irrigated with 5 mL of TauroPace™ solution.

The leads, device generator, and fixation sutures will then be thoroughly wiped using sterile gauze soaked in the solution. Once the leads are connected to the generator, the entire system will be treated again with TauroPace™ before being inserted into the pocket.

At the end of the procedure, the final surgical site will be irrigated once more with an additional 5 mL of TauroPace™ using a sterile syringe. A full 100 mL vial of the solution will be used for each patient, ensuring continuous antimicrobial coverage throughout the procedure.

Excess solution will be gently removed prior to surgical wound closure.

Primary outcomes

  1. incidence of CIEDs related infections

    Time frame: From enrollment to the end of 12 months

    To determine the incidence of infections related to cardiovascular implantable electronic devices (CIEDs) at 12 months in patients who received TauroPace™ during the implantation procedure.

Secondary outcomes

  1. Safety Profile of TauroPace™

    Time frame: From enrollment to 1 week after implantation

    To detect and describe any adverse events potentially related to the use of TauroPace

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Curcio

CONTACT

[email protected]

+390984681889

Sponsors and collaborators

Lead sponsor

University of Calabria

Other

Registry information

Official study title

Prevention of Infections Associated With Implantable Cardiac Devices

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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