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

Last updated: April 2, 2025
Sponsor: University of Kiel
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

TauroPace™

Clinical Study ID

NCT04735666
1.1
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Use of TauroPace™ is indicated and not contra-indicated according to its currentInstructions For Use (IFU)

  • Participant is eligible for a CIED related surgery procedure.

Exclusion

Exclusion Criteria:

  • Age<18years

  • Participant incapable of signing Patient Informed Consent (mentally or physically)or does not sign.

Study Design

Total Participants: 2300
Treatment Group(s): 1
Primary Treatment: TauroPace™
Phase:
Study Start date:
February 22, 2021
Estimated Completion Date:
January 30, 2030

Study 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).

Connect with a study center

  • Landeskrankenhaus Wiener Neustadt

    Wiener Neustadt, 2700
    Austria

    Site Not Available

  • Louis Pradel Hospital

    Lyon, Bron 69500
    France

    Site Not Available

  • Klinikum Freising

    Freising, Bavaria 85354
    Germany

    Site Not Available

  • Krankenhaus Landshut Achdorf

    Landshut, Bavaria 84036
    Germany

    Site Not Available

  • Helios Klinik Cuxhaven

    Cuxhaven, Niedersachsen 27474
    Germany

    Active - Recruiting

  • Helios Klinik Wesermarsch

    Nordenham, Niedersachsen 26954
    Germany

    Active - Recruiting

  • University Hospital Schleswig-Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Completed

  • Ospedale Regionale San Maurizio

    Bolzano, Alto Adige 39100
    Italy

    Site Not Available

  • The Great Western Hospital

    Swindon, Wiltshire SN3 6BB
    United Kingdom

    Site Not Available

  • Great Western Hospitals NHS Foundation Trust

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

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