NCT04735666

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,300 (estimated)
• Sponsor: University of Kiel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• CIED Related Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-22
• Primary completion: 2030-01-30
• Completion: 2030-01-30
• First posted: 2021-02-03
• Last updated: 2025-04-06

Locations

8 sites across 5 countries: Austria, France, Germany, Italy, United Kingdom