CIED Related InfectionETPRNCT04735666
European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
An observational study of CIED Related Infection, run by University of Kiel at 8 sites in 5 countries.
Trial summary
University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIED Related Infection
- What is being tested?
- TauroPace™
- Type of treatment
- Medical device
- How many people
- 2,300 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 22 Feb 2021to 30 Jan 2030
- How long will I take part?
- 3 Months
- 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: The study population consist of every subsequent participant eligible for any CIED related surgery with TauroPace™
Who may be able to join
- Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU)
- Participant is eligible for a CIED related surgery procedure.
Who cannot join
- Age<18years
- Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany4 sites
Helios Klinik Cuxhaven
Cuxhaven, Lower Saxony, 27474
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Krankenhaus Landshut Achdorf
Landshut, Bavaria, 84036
Helios Klinik Wesermarsch
Nordenham, Lower Saxony, 26954
United Kingdom1 site
Great Western Hospitals NHS Foundation Trust
Swindon, SN3 6BB
About this study
University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct TauroPace. It is planned to include a total of at least 2300 procedures (valid for safety analysis).
Read the detailed description
This study is performed as an all-case investigation. The treatment is performed based on the SOPs (Appendix Study Protocol). The standard observation period is 3 months from the 1st treatment. Safety and effectiveness are evaluated at 3rd and 12th month. In addition, the extension observation is carried out once a year for 3 years at the longest to collect information on safety and effectiveness as long as CIED treatment continues. When the treatment ends (extraction of all hardware), observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using a unique Case Report Form (CRF) system. The duration of the study is estimated at 10 years (registry).
- Conditions
- CIED Related Infection
- Being tested
- TauroPace™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauroPace™Device
TauroPace™ is intended to be used as a disinfecting solution during any CIED related surgery procedure or handling of any uncoated or silicon-, epoxy- or polyurethane-coated CIED (including its components, e.g., leads) made of titan or stainless steel in any adult patient requiring or carrying a CIED.
What is being measured
The primary outcome is the main question the study is designed to answer.
CIED infections
CIED infections occurring in an observation period of three months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.
Measured: three months
Secondary outcomes (4)
CIED infections
CIED infections occurring in an observation period of 12 months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.
Measured: 12 months
CIED infections
CIED infections occurring in an observation period of 36 months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.
Measured: 36 months
AE
Adverse events (complications) during 3, 12 and 36 months follow-up
Measured: 3, 12 and 36 months
All-cause mortality
Allcause mortality during 3, 12 and 36 months follow-up
Measured: 3, 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start22 Feb 2021
- Primary completion30 Jan 2030 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CIED Related InfectionStudies 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
- 2,300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Principal investigator, Prof. Dr. Hendrik Bonnemeier, University of Kiel
- Investigators
- Hendrik Bonnemeier, PhD, Principal investigator, University of Kiel - Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735666
- Sponsor's protocol ID
- 1.1
- Acronym
- ETPR
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data is recorded in a pseudonymous manner in the centre, before statistical analysis data is anonymized
Publications
Vonthein R, Baldauf B, Borov S, Lau EW, Giaccardi M, Assadian O, Haddad C, Chevalier P, Bode K, Foley P, Thomas H, Campbell NG, Fichtner S, Donazzan L, Pescoller F, Oberhollenzer R, Cemin R, Bonnemeier H. Taurolidine-containing solution for reducing cardiac implantable electronic device infection-early report from the European TauroPace registry. J Cardiothorac Surg. 2024 Oct 4;19(1):592. doi: 10.1186/s13019-024-03059-1.
PubMed 39367427
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT04735666
- Acronym / sponsor ID
- ETPR / 1.1
- Conditions
- CIED Related Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 3 Feb 2021 (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.
University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct TauroPace. It is planned to include a total of at least 2300 procedures (valid for safety analysis).
Detailed description
This study is performed as an all-case investigation. The treatment is performed based on the SOPs (Appendix Study Protocol). The standard observation period is 3 months from the 1st treatment. Safety and effectiveness are evaluated at 3rd and 12th month. In addition, the extension observation is carried out once a year for 3 years at the longest to collect information on safety and effectiveness as long as CIED treatment continues. When the treatment ends (extraction of all hardware), observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using a unique Case Report Form (CRF) system. The duration of the study is estimated at 10 years (registry).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist of every subsequent participant eligible for any CIED related surgery with TauroPace™
Key inclusion criteria (2 listed)
- Use of TauroPace™ is indicated and not contra-indicated according to its current Instructions For Use (IFU)
- Participant is eligible for a CIED related surgery procedure.
Key exclusion criteria (2 listed)
- Age<18years
- Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
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™TauroPace™ is intended to be used as a disinfecting solution during any CIED related surgery procedure or handling of any uncoated or silicon-, epoxy- or polyurethane-coated CIED (including its components, e.g., leads) made of titan or stainless steel in any adult patient requiring or carrying a CIED. | Device | – |
Primary outcome
CIED infections
Time frame: three months
CIED infections occurring in an observation period of three months after any CIED related surgical procedure in different CIED using a regimen with surface disinfection of CIEDs and irrigation of the surgical site (pocket) with a taurolidine containing antimicrobial compound adjunct.
4 secondary outcomes
CIED infections
Time frame: 12 months
CIED infections
Time frame: 36 months
AE
Time frame: 3, 12 and 36 months
All-cause mortality
Time frame: 3, 12 and 36 months
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 1 May 2026.
- Derived from this study: PubMed 39367427Vonthein R, Baldauf B, Borov S, Lau EW, Giaccardi M, Assadian O, Haddad C, Chevalier P, Bode K, Foley P, Thomas H, Campbell NG, Fichtner S, Donazzan L, Pescoller F, Oberhollenzer R, Cemin R, Bonnemeier H. Taurolidine-containing solution for reducing cardiac implantable electronic device infection-early report from the European TauroPace registry. J Cardiothorac Surg. 2024 Oct 4;19(1):592. doi: 10.1186/s13019-024-03059-1.
- domain of the EuropeanTauroPace RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: No. participant data is recorded in a pseudonymous manner in the centre, before statistical analysis data is anonymized
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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. This study is not recruiting at the moment.
Hendrik Bonnemeier, PhD principal investigator
University of Kiel - Medical Faculty
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIED Related Infection, run by University of Kiel at 8 sites in 5 countries.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, France, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIED infections (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735666, which also lists 1 linked publication.
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 1 May 2026.