Clinical trial NCT04735666: European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
Official title: European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CIED Related Infection
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: University of Luebeck
First posted: 2021-02-03
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consist of every subsequent participant eligible for any CIED related surgery with TauroPace™

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).

Eligibility criteria: 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.

Primary outcomes:
measure: CIED infections
timeFrame: three months
Secondary outcomes:
measure: CIED infections
timeFrame: 12 months
measure: CIED infections
timeFrame: 36 months
measure: AE
timeFrame: 3, 12 and 36 months
measure: All-cause mortality
timeFrame: 3, 12 and 36 months
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: Landeskrankenhaus Wiener Neustadt
city: Lyon
country: France
facility: Louis Pradel Hospital
state: Bron
city: Landshut
country: Germany
facility: Krankenhaus Landshut Achdorf
state: Bavaria
city: Cuxhaven
country: Germany
facility: Helios Klinik Cuxhaven
state: Niedersachsen
city: Nordenham
country: Germany
facility: Helios Klinik Wesermarsch
state: Niedersachsen
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Bolzano
country: Italy
facility: Ospedale Regionale San Maurizio
state: Alto Adige
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Kiel - Medical Faculty
name: Hendrik Bonnemeier, PhD
role: PRINCIPAL_INVESTIGATOR
References: