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

Sponsor

ICU Medical Technologies S.L. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05351658

Collaborator

Universidad Miguel Hernandez de Elche (Other)

122

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrythmia Bradycardia	Device: KronoSafe® System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Temporary Cardiac Pacing with Active-Fixation Leads

Device: KronoSafe® System

All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.

Outcome Measures

Primary Outcome Measures

Ventricular R wave detection [Immediately after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection [Immediately after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Right ventricle threshold detection [Immediately after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Ventricular R wave detection [24 hours after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 3 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 5 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 7 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 9 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 11 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 13 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 15 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 17 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 19 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 21 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 23 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 25 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 27 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [day 29 after the procedure of lead implantation]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection [Immediately before the procedure of lead removal]
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection [24 hours after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 3 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 5 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 7 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 9 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 11 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 13 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 15 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 17 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 19 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 21 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 23 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 25 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 27 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [day 29 after the procedure of lead implantation]
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection [Immediately before the procedure of lead removal]
Lead impedance, measured in ohms with pacemaker generator programmer
Right ventricle threshold detection [24 hours after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 3 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 5 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 7 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 9 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 11 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 13 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 15 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 17 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 19 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 21 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 23 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 25 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 27 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection [day 29 after the procedure of lead implantation]
Right ventricle threshold, measured in volts with pacemaker generator programmer
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.
Sensing failure detection [Immediately before the procedure of lead removal]
Ventricular R wave below 1 volt, 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
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.
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%

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.