Clinical trial NCT05351658: Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Official title: Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrythmia
Bradycardia
Keywords: Pacemaker
Cardiac pacing
Bradycardia
Arrhythmia
Treatment outcome
Lead sponsor: ICU Medical Technologies S.L.
Sponsor class: INDUSTRY
Collaborators: name: Universidad Miguel Hernandez de Elche
First posted: 2022-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ventricular R wave detection
timeFrame: Immediately after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: Immediately after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: Immediately after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: 24 hours after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 3 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 5 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 7 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 9 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 11 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 13 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 15 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 17 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 19 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 21 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 23 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 25 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 27 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: day 29 after the procedure of lead implantation
measure: Ventricular R wave detection
timeFrame: Immediately before the procedure of lead removal
measure: Lead impedance detection
timeFrame: 24 hours after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 3 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 5 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 7 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 9 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 11 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 13 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 15 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 17 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 19 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 21 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 23 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 25 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 27 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: day 29 after the procedure of lead implantation
measure: Lead impedance detection
timeFrame: Immediately before the procedure of lead removal
measure: Right ventricle threshold detection
timeFrame: 24 hours after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 3 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 5 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 7 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 9 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 11 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 13 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 15 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 17 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 19 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 21 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 23 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 25 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 27 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: day 29 after the procedure of lead implantation
measure: Right ventricle threshold detection
timeFrame: Immediately before the procedure of lead removal
measure: Lead displacement detection
timeFrame: Immediately before the procedure of lead removal
measure: Capture failure detection
timeFrame: Immediately before the procedure of lead removal
measure: Sensing failure detection
timeFrame: Immediately before the procedure of lead removal
measure: Lead insulation breakdown detection
timeFrame: Immediately before the procedure of lead removal
measure: Generator detachment detection
timeFrame: Immediately before the procedure of lead removal
measure: Cardiac peroration detection
timeFrame: Immediately before the procedure of lead removal
Secondary outcomes:
measure: Detection of Bacteremia
timeFrame: Immediately after the procedure of lead removal
measure: Detection of Agitation
timeFrame: Immediately after the procedure of lead removal
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Dr.Balmis
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
Study officials:
affiliation: Intensive Care Physician at Dr. Balmis University Hospital (Alicante)
name: Raimundo Vicente, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.