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NCT07158502

Antimicrobial Strategy for Device Implantation

Not yet recruiting Last updated 5 September 2025
What this trial tests

trial testing TauroPace Cohort in CIED-related Infections in 1,000 participants. Not yet recruiting.

Timeline
1 September 2025
Primary endpoint
30 September 2027
31 December 2027

Quick facts

Lead sponsorUniversity of Calabria
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 September 2025
Primary completion30 September 2027
Estimated completion31 December 2027

Drugs / interventions tested

Conditions studied

Sponsor

University of Calabria

Who can join

18 and older, any sex, with CIED-related Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for CIED-related Infections

Currently open trials in the same condition.

Other University of Calabria trials

Trials by the same sponsor.

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Data sources for this page

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