CIED Related Infection
Conditions
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).
Interventions
DEVICETauroPace™
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.
Sponsors
University of Kiel
University of Luebeck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIED infections | 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
| Measure | Time frame | Description |
|---|---|---|
| CIED infections | 12 months | 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. |
| AE | 3, 12 and 36 months | Adverse events (complications) during 3, 12 and 36 months follow-up |
| All-cause mortality | 3, 12 and 36 months | Allcause mortality during 3, 12 and 36 months follow-up |
Countries
Austria, France, Germany, Italy, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORHendrik Bonnemeier, PhD
University of Kiel - Medical Faculty
Outcome results
None listed