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

Bradycardia Clinical Trial

— TEMPACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351658
• Other study ID #: TEMPACE
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: ICU Medical Technologies S.L.
• Contact: Raimundo Vicente, MD
• Phone: +34 965933000
• Email: tempace[@]icumedic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Bradycardia

Intervention

Device:
• KronoSafe® System
All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante Dr.Balmis	Alicante
Spain	Hospital Universitari Vall D'Hebron	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
ICU Medical Technologies S.L.	Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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 — View 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-fixatio — View 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 abstrac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	Immediately after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	Immediately after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	Immediately after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	24 hours after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 3 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 5 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 7 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 9 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 11 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 13 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 15 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 17 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 19 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 21 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 23 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 25 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 27 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	day 29 after the procedure of lead implantation
Primary	Ventricular R wave detection	Ventricular R wave, measured in millivolts with pacemaker generator programmer	Immediately before the procedure of lead removal
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	24 hours after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 3 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 5 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 7 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 9 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 11 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 13 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 15 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 17 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 19 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 21 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 23 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 25 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 27 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	day 29 after the procedure of lead implantation
Primary	Lead impedance detection	Lead impedance, measured in ohms with pacemaker generator programmer	Immediately before the procedure of lead removal
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	24 hours after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 3 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 5 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 7 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 9 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 11 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 13 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 15 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 17 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 19 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 21 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 23 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 25 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 27 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	day 29 after the procedure of lead implantation
Primary	Right ventricle threshold detection	Right ventricle threshold, measured in volts with pacemaker generator programmer	Immediately before the procedure of lead removal
Primary	Lead displacement detection	Visual observation of 2 cm electrode displacement through vein acces by clinical examination	Immediately before the procedure of lead removal
Primary	Capture failure detection	Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.	Immediately before the procedure of lead removal
Primary	Sensing failure detection	Ventricular R wave below 1 volt, measured with pacemaker generator programmer	Immediately before the procedure of lead removal
Primary	Lead insulation breakdown detection	Visual observation of lead insulation breakdown by clinical examination	Immediately before the procedure of lead removal
Primary	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
Primary	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	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
Secondary	Detection of Agitation	Record of antipsychotic and anxiolytic treatment of the patient	Immediately after the procedure of lead removal