Trials / Completed
CompletedNCT05351658
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- ICU Medical Technologies S.L. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label (non-certificated) use of Pacemaker leads and generators. It is designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. The aim of this study is to demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | KronoSafe® System | All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system. |
Timeline
- Start date
- 2023-01-05
- Primary completion
- 2024-11-18
- Completion
- 2024-12-31
- First posted
- 2022-04-28
- Last updated
- 2025-04-20
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05351658. Inclusion in this directory is not an endorsement.