CIED-related InfectionsNCT07158502
Antimicrobial Strategy for Device Implantation
An observational study of CIED-related Infections, run by University of Calabria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIED-related Infections
- What is being tested?
- TauroPace Cohort
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years
- Clinical indication for CIED implantation or generator replacement
- Signed informed consent to participate in the study
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevention of Infections Associated With Implantable Cardiac Devices
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
- Being tested
- TauroPace Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauroPace CohortDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TauroPace Cohort | Not described Receives: Drug: TauroPace Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of 12 months
Secondary outcomes (1)
Safety Profile of TauroPace™
To detect and describe any adverse events potentially related to the use of TauroPace
Measured: From enrollment to 1 week after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIED-related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calabria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Curcio, University of Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158502
- Sponsor's protocol ID
- 195/2025
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Infections Associated With Implantable Cardiac Devices
- ClinicalTrials.gov ID
- NCT07158502
- Acronym / sponsor ID
- 195/2025
- Conditions
- CIED-related Infections
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CalabriaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TauroPace Cohort | – | Drug: TauroPace Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Clinical indication for CIED implantation or generator replacement
- Signed informed consent to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TauroPace CohortAfter 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. | Drug | TauroPace Cohort |
Primary outcome
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.
1 secondary outcome
Safety Profile of TauroPace™
Time frame: From enrollment to 1 week after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of CIED-related Infections, run by University of Calabria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Curcio (+390984681889, antonio.curcio.cardio@unical.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CIEDs related infections (time frame: From enrollment to the end of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.