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

University of Kiel

Status: Enrolling

Conditions: CIED Related Infection

Treatments: Device: TauroPace™

Study type: Observational

Funder types: Other

Identifiers

NCT04735666

1.1

Details and patient eligibility

About

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).

Full 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).

Enrollment: 2,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.