Antimicrobial Strategy for Device Implantation

NCT07158502 | Not Yet Recruiting

• 1 other identifier: 195/2025
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CIED-related Infections

Outcome Measures

Primary Outcomes (1)

• incidence of CIEDs related infections

  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.

  From enrollment to the end of 12 months

Secondary Outcomes (1)

• Safety Profile of TauroPace™

  From enrollment to 1 week after implantation

Study Arms (1)

TauroPace Cohort

Drug: TauroPace Cohort

Interventions

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.

TauroPace Cohort

Eligibility Criteria

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

Study Population

Patients undergoing implantation or generator replacement of cardiovascular implantable electronic devices (CIEDs). Participants will be consecutively enrolled during routine clinical activity over the study period.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calabria: lead

Central Study Contacts

Antonio Curcio

CONTACT

+390984681889; antonio.curcio.cardio@unical.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share