Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)

Not Applicable

Completed

• Conditions: Arrythmia; Bradycardia
• Interventions: Device: KronoSafe® System

• Registration Number: NCT05351658
• Lead Sponsor: ICU Medical Technologies S.L.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-28
• Study Start: 2023-01-05
• Primary Completion: 2024-11-18
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temporary Cardiac Pacing with Active-Fixation Leads	KronoSafe® System	-

Primary Outcome Measures

Name	Time	Method
Right ventricle threshold detection	Immediately before the procedure of lead removal	Right ventricle threshold, measured in volts with pacemaker generator programmer
Lead displacement detection	Immediately before the procedure of lead removal	Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Capture failure detection	Immediately before the procedure of lead removal	Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Lead insulation breakdown detection	Immediately before the procedure of lead removal	Visual observation of lead insulation breakdown by clinical examination
Cardiac peroration detection	Immediately before the procedure of lead removal	New pericardial effusion detected by Echocardiography with signs of cardiac tamponade: respiratory variation of transmitral filling flow greater than 25%
Ventricular R wave detection	Immediately before the procedure of lead removal	Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection	Immediately before the procedure of lead removal	Lead impedance, measured in ohms with pacemaker generator programmer
Sensing failure detection	Immediately before the procedure of lead removal	Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Generator detachment detection	Immediately before the procedure of lead removal	Visual observation of generator detachment by clinical examination. removal of the generator from the casing.

Secondary Outcome Measures

Name	Time	Method
Detection of Bacteremia	Immediately after the procedure of lead removal	Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient
Detection of Agitation	Immediately after the procedure of lead removal	Record of antipsychotic and anxiolytic treatment of the patient

Trial Locations

Locations (2)

Hospital General Universitario de Alicante Dr.Balmis; 🇪🇸 Alicante, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain