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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.
Hospital General Universitario de Alicante Dr.Balmis
Alicante, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: Immediately after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: Immediately after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: Immediately after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: 24 hours after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 3 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 5 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 7 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 9 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 11 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 13 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 15 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 17 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 19 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 21 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 23 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 25 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 27 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: day 29 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time frame: Immediately before the procedure of lead removal
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: 24 hours after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 3 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 5 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 7 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 9 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 11 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 13 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 15 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 17 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 19 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 21 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 23 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 25 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 27 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: day 29 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Time frame: Immediately before the procedure of lead removal
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: 24 hours after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 3 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 5 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 7 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 9 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 11 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 13 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 15 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 17 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 19 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 21 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 23 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 25 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 27 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: day 29 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time frame: Immediately before the procedure of lead removal
Lead displacement detection
Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Time frame: Immediately before the procedure of lead removal
Capture failure detection
Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Time frame: Immediately before the procedure of lead removal
Sensing failure detection
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Time frame: Immediately before the procedure of lead removal
Lead insulation breakdown detection
Visual observation of lead insulation breakdown by clinical examination
Time frame: 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.
Time frame: 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%
Time frame: Immediately before the procedure of lead removal
Detection of Bacteremia
Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient
Time frame: Immediately after the procedure of lead removal
Detection of Agitation
Record of antipsychotic and anxiolytic treatment of the patient
Time frame: Immediately after the procedure of lead removal
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