Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-27 @ 3:20 AM
Study NCT ID:
NCT04735666
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
Sponsor:
University of Kiel
Organization:
Study Overview
Official Title:
European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETPR
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: