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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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CIED Related Infection

Intervention / Treatment
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* Device: TauroPace™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| AE | Adverse events (complications) during 3, 12 and 36 months follow-up | 3, 12 and 36 months | 
| All-cause mortality | Allcause mortality during 3, 12 and 36 months follow-up | 3, 12 and 36 months |