Status:
COMPLETED
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Lead Sponsor:
ICU Medical Technologies S.L.
Collaborating Sponsors:
Universidad Miguel Hernandez de Elche
Conditions:
Arrythmia
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 of...
Eligibility Criteria
Inclusion
- Patient older than 18 years.
- Need for temporary cardiac stimulation
- Temporary active fixation pacemaker implantation through left or right jugular access.
- Signature of informed consent
- Correct functioning of the electrode after the implantation: sensing of the R wave above 5 millivolts. Ventricular pacing threshold below 1 volt. Electrode impedance between 400-1200 Ohm.
- Pacemaker programming with stimulation output at 5 volts intensity and 1 millisecond pulse duration.
- Placement of the KronoSafe® fastening system after electrode implantation.
Exclusion
- Complication during the procedure: pneumothorax, hematoma at the puncture site, cardiac perforation, accidental arterial puncture or other that, in the investigator's opinion, poses an added risk of pacemaker dysfunction.
- Need to transfer the patient to another center with loss of follow-up.
- Absence of surveillance through continuous electrocardiographic monitoring with detection of arrhythmic events.
Key Trial Info
Start Date :
January 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05351658
Start Date
January 5 2023
End Date
December 31 2024
Last Update
April 20 2025
Active Locations (2)
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1
Hospital General Universitario de Alicante Dr.Balmis
Alicante, Spain, 03010
2
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035