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

November 30, 2023 updated by: Prof. Dr. Hendrik Bonnemeier, University of Kiel
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Wiener Neustadt, Austria, 2700
        • Not yet recruiting
        • Landeskrankenhaus Wiener Neustadt
        • Contact:
        • Sub-Investigator:
          • Alexander Teubl, MD
        • Principal Investigator:
          • Ojan Assadian, Prof.
  • France
  • Germany
    • Bavaria
      • Freising, Bavaria, Germany, 85354
        • Not yet recruiting
        • Klinikum Freising
        • Principal Investigator:
          • Stefan Borov, MD
        • Contact:
      • Landshut, Bavaria, Germany, 84036
        • Active, not recruiting
        • Krankenhaus Landshut Achdorf
    • Niedersachsen
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Completed
        • University Hospital Schleswig-Holstein
  • Italy
    • Alto Adige
      • Bolzano, Alto Adige, Italy, 39100
  • United Kingdom
      • Swindon, United Kingdom, SN3 6BB
        • Active, not recruiting
        • Great Western Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CIED infections
Time Frame: 12 months
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.
12 months
CIED infections
Time Frame: 36 months
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.
36 months
AE
Time Frame: 3, 12 and 36 months
Adverse events (complications) during 3, 12 and 36 months follow-up
3, 12 and 36 months
All-cause mortality
Time Frame: 3, 12 and 36 months
Allcause mortality during 3, 12 and 36 months follow-up
3, 12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kiel

Collaborators

University of Luebeck

Investigators

  • Principal Investigator: Hendrik Bonnemeier, PhD, University of Kiel - Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2030

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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