Antimicrobial Strategy for Device Implantation

University of Calabria

Status: Not yet enrolling

Conditions: CIED-related Infections

Treatments: Drug: TauroPace Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07158502

195/2025

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

TauroPace Cohort

Treatment:

Drug: TauroPace Cohort