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

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 Overview

• Status: Completed
• Conditions: Bradycardia; Arrythmia
• Intervention / Treatment: Device: KronoSafe® System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante Dr.Balmis
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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	Immediately after the procedure of lead removal

Collaborators and Investigators

• Sponsor: ICU Medical Technologies S.L.
• Collaborators: Universidad Miguel Hernandez de Elche
• Investigators: Principal Investigator: Raimundo Vicente, MD, Intensive Care Physician at Dr. Balmis University Hospital (Alicante)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Arrhythmia; Treatment outcome; Pacemaker; Cardiac pacing; Bradycardia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Bradycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: TEMPACE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No