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

CIED Related Infection Clinical Trial

— ETPR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735666
• Other study ID #: 1.1
• Status: Recruiting
• Start date: February 22, 2021
• Est. completion date: January 30, 2030

Study information

• Verified date: November 2023
• Source: University of Kiel
• Contact: Clinician scientist, MD
• Phone: +11-49-17696450666
• Email: sportmedic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2300
• Est. completion date: January 30, 2030
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CIED Related Infection

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Wiener Neustadt	Wiener Neustadt
France	Louis Pradel Hospital	Lyon	Bron
Germany	Helios Klinik Cuxhaven	Cuxhaven	Niedersachsen
Germany	Klinikum Freising	Freising	Bavaria
Germany	University Hospital Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Krankenhaus Landshut Achdorf	Landshut	Bavaria
Germany	Helios Klinik Wesermarsch	Nordenham	Niedersachsen
Italy	Ospedale Regionale San Maurizio	Bolzano	Alto Adige
United Kingdom	Great Western Hospitals NHS Foundation Trust	Swindon

Sponsors (2)

Lead Sponsor	Collaborator
University of Kiel	University of Luebeck

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CIED infections	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
Secondary	CIED infections	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
Secondary	AE	Adverse events (complications) during 3, 12 and 36 months follow-up	3, 12 and 36 months
Secondary	All-cause mortality	Allcause mortality during 3, 12 and 36 months follow-up	3, 12 and 36 months

External Links

•   domain of the EuropeanTauroPace Registry