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| Name | Class |
|---|---|
| Universidad Miguel Hernandez de Elche | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporary Cardiac Pacing with Active-Fixation Leads | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KronoSafe® System | Device | All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raimundo Vicente, MD | Intensive Care Physician at Dr. Balmis University Hospital (Alicante) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Alicante Dr.Balmis | Alicante | 03010 | Spain | |||
| Hospital Universitari Vall D'Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34918044 | Result | Vicente-Miralles R, Martin-Langerwerf DA, Nunez-Martinez JM, Marco-Juan A, Sangio-Ferreyros AD, Davila-Arias A, Montes-Jacobo L, Barrios V, Palazon-Bru A, Gil-Guillen VF, Bertomeu-Gonzalez V. A new fastening system for temporary pacing with active-fixation leads: effectiveness and safety. Eur Heart J Acute Cardiovasc Care. 2022 Mar 16;11(3):224-229. doi: 10.1093/ehjacc/zuab119. | |
| 16580542 |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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 |
| Immediately after the procedure of lead removal |
| Barcelona |
| 08035 |
| Spain |
| Result |
| Zei PC, Eckart RE, Epstein LM. Modified temporary cardiac pacing using transvenous active fixation leads and external re-sterilized pulse generators. J Am Coll Cardiol. 2006 Apr 4;47(7):1487-9. doi: 10.1016/j.jacc.2006.01.006. Epub 2006 Mar 15. No abstract available. |
| 23482613 | Result | Kawata H, Pretorius V, Phan H, Mulpuru S, Gadiyaram V, Patel J, Steltzner D, Krummen D, Feld G, Birgersdotter-Green U. Utility and safety of temporary pacing using active fixation leads and externalized re-usable permanent pacemakers after lead extraction. Europace. 2013 Sep;15(9):1287-91. doi: 10.1093/europace/eut045. Epub 2013 Mar 12. |
| 12954959 | Result | Betts TR. Regional survey of temporary transvenous pacing procedures and complications. Postgrad Med J. 2003 Aug;79(934):463-5. doi: 10.1136/pmj.79.934.463. |
| 40875828 | Derived | Vicente-Miralles R, Rivas-Gandara N, Jordan Marchite P, Adelino R, Carmona MA, Diaz Barranco M, Ibanez Criado AA, Ruiz Nodar JM, Ajo Ferrer M, Garcia-Fernandez A, Bertomeu-Gonzalez V, Martinez Martinez JG. A novel device for temporary cardiac stimulation using permanent pacemaker generators and active-fixation leads: the TEMPACE multicentre prospective study. Eur Heart J Acute Cardiovasc Care. 2026 Jan 23;14(12):732-738. doi: 10.1093/ehjacc/zuaf111. |