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European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study

NCT ID: NCT04735666

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2030-01-30

Brief Summary

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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).

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Detailed Description

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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

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CIED Related Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Age\<18years
* Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Hendrik Bonnemeier

Coordinating Investigator ETPR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hendrik Bonnemeier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kiel - Medical Faculty

Locations

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Landeskrankenhaus Wiener Neustadt

Wiener Neustadt, , Austria

Site Status NOT_YET_RECRUITING

Louis Pradel Hospital

Lyon, Bron, France

Site Status NOT_YET_RECRUITING

Krankenhaus Landshut Achdorf

Landshut, Bavaria, Germany

Site Status ACTIVE_NOT_RECRUITING

Helios Klinik Cuxhaven

Cuxhaven, Lower Saxony, Germany

Site Status RECRUITING

Helios Klinik Wesermarsch

Nordenham, Lower Saxony, Germany

Site Status RECRUITING

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status COMPLETED

Ospedale Regionale San Maurizio

Bolzano, Trentino-Alto Adige, Italy

Site Status NOT_YET_RECRUITING

Great Western Hospitals NHS Foundation Trust

Swindon, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Austria France Germany Italy United Kingdom

Central Contacts

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Clinician scientist, MD

Role: CONTACT

[email protected]
+11-49-17696450666

Jana Henke

Role: CONTACT

[email protected]

Facility Contacts

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Ojan Assadian, Prof.

Role: primary

[email protected]

Philippe Chevalier, PhD

Role: primary

[email protected]

Hendrik Bonnemeier, PhD

Role: primary

[email protected]

Clinician Scientist, MD

Role: backup

[email protected]

Hendrik Bonnemeier, PhD

Role: primary

[email protected]

Clinician Scientist, MD

Role: backup

[email protected]

Roberto Cemin, MD

Role: primary

[email protected]

References

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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.

Reference Type DERIVED
PMID: 39367427 (View on PubMed)

Related Links

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http://www.etpr.eu

domain of the EuropeanTauroPace Registry

Other Identifiers

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1.1

Identifier Type: -

Identifier Source: org_study_id

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