NCT04735666

Brief 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 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).

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
5 countries

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Feb 2021Jan 2030

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

8.9 years

First QC Date

January 29, 2021

Last Update Submit

April 27, 2026

Conditions

CIED Related Infection

Outcome Measures

Primary Outcomes (1)

  • 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.

    three months

Secondary Outcomes (4)

  • CIED infections

    12 months

  • CIED infections

    36 months

  • AE

    3, 12 and 36 months

  • All-cause mortality

    3, 12 and 36 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consist of every subsequent participant eligible for any CIED related surgery with TauroPace™

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Landeskrankenhaus Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Louis Pradel Hospital

Lyon, Bron, 69500, France

Location

Krankenhaus Landshut Achdorf

Landshut, Bavaria, 84036, Germany

Location

Helios Klinik Cuxhaven

Cuxhaven, Lower Saxony, 27474, Germany

Location

Helios Klinik Wesermarsch

Nordenham, Lower Saxony, 26954, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Ospedale Regionale San Maurizio

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

Great Western Hospitals NHS Foundation Trust

Swindon, SN3 6BB, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 39367427DERIVED

Related Links

Study Officials

  • Hendrik Bonnemeier, PhD

    University of Kiel - Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator ETPR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

February 22, 2021

Primary Completion (Estimated)

January 30, 2030

Study Completion (Estimated)

January 30, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

participant data is recorded in a pseudonymous manner in the centre, before statistical analysis data is anonymized

Locations

AU(1)FR(1)DE(4)IT(1)GB(1)