Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04735666 |
| Other study ID # |
1.1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 22, 2021 |
| Est. completion date |
January 30, 2030 |
Study information
| Verified date |
November 2023 |
| Source |
University of Kiel |
| Contact |
Clinician scientist, MD |
| Phone |
+11-49-17696450666 |
| Email |
sportmedic[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
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).
