European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
University of Kiel
2,300 participants
Feb 22, 2021
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria2
- 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 Criteria2
- Age<18years
- Participant incapable of signing Patient Informed Consent (mentally or physically) or does not sign.
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Interventions
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.
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT04735666