European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Kiel
- Enrollment
- 2,300
- Locations
- 8
- Primary Endpoint
- CIED infections
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
CIED infections
Time Frame: three months
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.
Secondary Outcomes
- CIED infections(12 months)
- AE(3, 12 and 36 months)
- All-cause mortality(3, 12 and 36 months)
- CIED infections(36 months)
Investigators
Prof. Dr. Hendrik Bonnemeier
Coordinating Investigator ETPR
University of Kiel