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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arrythmia, Bradycardia

Intervention / Treatment
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* Device: KronoSafe® System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The study will be carried out in an Arrhythmia Unit or Intensive Care Unit. Patients who need urgent temporary cardiac pacing due to bradycardia, or elective pacing to prevent heart rhythm disturbances during high-risk arrhythmia interventions, such as transcatheter aortic valve implantation (TAVR), alcoholic septal ablations, etc., will be included. After the temporary pacemaker implantation with active fixation electrode in a correct way, the KronoSafe® external pacemaker fixation system will be placed. The correct functioning of the system (R wave detection, lead impedance and right ventricle threshold) will be checked at 24 hours and every other day until the end of cardiac stimulation. During temporary pacing, associated complications are going to be recorded: lead displacement, capture or sensing failure, generator or lead detachment, and cardiac perforation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temporary Cardiac Pacing with Active-Fixation Leads<br> | Device: KronoSafe® System<br>* All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | Immediately after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | Immediately after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | Immediately after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | 24 hours after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 3 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 5 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 7 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 9 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 11 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 13 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 15 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 17 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 19 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 21 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 23 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 25 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 27 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | day 29 after the procedure of lead implantation | 
| Ventricular R wave detection | Ventricular R wave, measured in millivolts with pacemaker generator programmer | Immediately before the procedure of lead removal | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | 24 hours after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 3 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 5 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 7 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 9 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 11 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 13 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 15 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 17 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 19 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 21 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 23 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 25 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 27 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | day 29 after the procedure of lead implantation | 
| Lead impedance detection | Lead impedance, measured in ohms with pacemaker generator programmer | Immediately before the procedure of lead removal | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | 24 hours after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 3 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 5 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 7 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 9 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 11 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 13 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 15 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 17 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 19 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 21 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 23 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 25 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 27 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | day 29 after the procedure of lead implantation | 
| Right ventricle threshold detection | Right ventricle threshold, measured in volts with pacemaker generator programmer | Immediately before the procedure of lead removal | 
| Lead displacement detection | Visual observation of 2 cm electrode displacement through vein acces by clinical examination | Immediately before the procedure of lead removal | 
| Capture failure detection | Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer. | Immediately before the procedure of lead removal | 
| Sensing failure detection | Ventricular R wave below 1 volt, measured with pacemaker generator programmer | Immediately before the procedure of lead removal | 
| Lead insulation breakdown detection | Visual observation of lead insulation breakdown by clinical examination | Immediately before the procedure of lead removal | 
| Generator detachment detection | Visual observation of generator detachment by clinical examination. removal of the generator from the casing. | Immediately before the procedure of lead removal | 
| Cardiac peroration detection | New pericardial effusion detected by Echocardiography with signs of cardiac tamponade: respiratory variation of transmitral filling flow greater than 25% | Immediately before the procedure of lead removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Bacteremia | Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient | Immediately after the procedure of lead removal | 
| Detection of Agitation | Record of antipsychotic and anxiolytic treatment of the patient | Immediately after the procedure of lead removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Cardiac pacing, Bradycardia, Arrhythmia, Treatment outcome