Arrythmia, Bradycardia
Conditions
Keywords
Pacemaker, Cardiac pacing, Bradycardia, Arrhythmia, Treatment outcome
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.
Interventions
DEVICEKronoSafe® System
All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.
Sponsors
Universidad Miguel Hernandez de Elche
ICU Medical Technologies S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| 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. |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Agitation | Immediately after the procedure of lead removal | Record of antipsychotic and anxiolytic treatment of the patient |
| 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 |
Countries
Spain
Outcome results
None listed