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

Recruiting

• Conditions: CIED Related Infection

• Registration Number: NCT04735666
• Lead Sponsor: University of Kiel

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).

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 Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-02-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2030-01-30
• Study Completion: 2030-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CIED infections	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.

Secondary Outcome Measures

Name	Time	Method
AE	3, 12 and 36 months	Adverse events (complications) during 3, 12 and 36 months follow-up
All-cause mortality	3, 12 and 36 months	Allcause mortality during 3, 12 and 36 months follow-up
CIED infections	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.

Trial Locations

Locations (8)

Landeskrankenhaus Wiener Neustadt; 🇦🇹 Wiener Neustadt, Austria

Louis Pradel Hospital; 🇫🇷 Lyon, Bron, France

Krankenhaus Landshut Achdorf; 🇩🇪 Landshut, Bavaria, Germany

Helios Klinik Cuxhaven; 🇩🇪 Cuxhaven, Niedersachsen, Germany

Helios Klinik Wesermarsch; 🇩🇪 Nordenham, Niedersachsen, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Ospedale Regionale San Maurizio; 🇮🇹 Bolzano, Alto Adige, Italy

Great Western Hospitals NHS Foundation Trust; 🇬🇧 Swindon, United Kingdom