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Completed

NCT Number: NCT05351658

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

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Key information

Conditions

Arrythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario de Alicante Dr.Balmis, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KronoSafe® System

Device

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

Primary outcomes

  1. Ventricular R wave detection

    Time frame: Immediately after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  2. Lead impedance detection

    Time frame: Immediately after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  3. Right ventricle threshold detection

    Time frame: Immediately after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  4. Ventricular R wave detection

    Time frame: 24 hours after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  5. Ventricular R wave detection

    Time frame: day 3 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  6. Ventricular R wave detection

    Time frame: day 5 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  7. Ventricular R wave detection

    Time frame: day 7 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  8. Ventricular R wave detection

    Time frame: day 9 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  9. Ventricular R wave detection

    Time frame: day 11 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  10. Ventricular R wave detection

    Time frame: day 13 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  11. Ventricular R wave detection

    Time frame: day 15 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  12. Ventricular R wave detection

    Time frame: day 17 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  13. Ventricular R wave detection

    Time frame: day 19 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  14. Ventricular R wave detection

    Time frame: day 21 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  15. Ventricular R wave detection

    Time frame: day 23 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  16. Ventricular R wave detection

    Time frame: day 25 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  17. Ventricular R wave detection

    Time frame: day 27 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  18. Ventricular R wave detection

    Time frame: day 29 after the procedure of lead implantation

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  19. Ventricular R wave detection

    Time frame: Immediately before the procedure of lead removal

    Ventricular R wave, measured in millivolts with pacemaker generator programmer

  20. Lead impedance detection

    Time frame: 24 hours after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  21. Lead impedance detection

    Time frame: day 3 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  22. Lead impedance detection

    Time frame: day 5 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  23. Lead impedance detection

    Time frame: day 7 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  24. Lead impedance detection

    Time frame: day 9 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  25. Lead impedance detection

    Time frame: day 11 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  26. Lead impedance detection

    Time frame: day 13 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  27. Lead impedance detection

    Time frame: day 15 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  28. Lead impedance detection

    Time frame: day 17 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  29. Lead impedance detection

    Time frame: day 19 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  30. Lead impedance detection

    Time frame: day 21 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  31. Lead impedance detection

    Time frame: day 23 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  32. Lead impedance detection

    Time frame: day 25 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  33. Lead impedance detection

    Time frame: day 27 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  34. Lead impedance detection

    Time frame: day 29 after the procedure of lead implantation

    Lead impedance, measured in ohms with pacemaker generator programmer

  35. Lead impedance detection

    Time frame: Immediately before the procedure of lead removal

    Lead impedance, measured in ohms with pacemaker generator programmer

  36. Right ventricle threshold detection

    Time frame: 24 hours after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  37. Right ventricle threshold detection

    Time frame: day 3 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  38. Right ventricle threshold detection

    Time frame: day 5 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  39. Right ventricle threshold detection

    Time frame: day 7 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  40. Right ventricle threshold detection

    Time frame: day 9 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  41. Right ventricle threshold detection

    Time frame: day 11 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  42. Right ventricle threshold detection

    Time frame: day 13 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  43. Right ventricle threshold detection

    Time frame: day 15 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  44. Right ventricle threshold detection

    Time frame: day 17 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  45. Right ventricle threshold detection

    Time frame: day 19 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  46. Right ventricle threshold detection

    Time frame: day 21 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  47. Right ventricle threshold detection

    Time frame: day 23 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  48. Right ventricle threshold detection

    Time frame: day 25 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  49. Right ventricle threshold detection

    Time frame: day 27 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  50. Right ventricle threshold detection

    Time frame: day 29 after the procedure of lead implantation

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  51. Right ventricle threshold detection

    Time frame: Immediately before the procedure of lead removal

    Right ventricle threshold, measured in volts with pacemaker generator programmer

  52. Lead displacement detection

    Time frame: Immediately before the procedure of lead removal

    Visual observation of 2 cm electrode displacement through vein acces by clinical examination

  53. Capture failure detection

    Time frame: Immediately before the procedure of lead removal

    Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.

  54. Sensing failure detection

    Time frame: Immediately before the procedure of lead removal

    Ventricular R wave below 1 volt, measured with pacemaker generator programmer

  55. Lead insulation breakdown detection

    Time frame: Immediately before the procedure of lead removal

    Visual observation of lead insulation breakdown by clinical examination

  56. Generator detachment detection

    Time frame: Immediately before the procedure of lead removal

    Visual observation of generator detachment by clinical examination. removal of the generator from the casing.

  57. Cardiac peroration detection

    Time frame: 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%

Secondary outcomes

  1. Detection of Bacteremia

    Time frame: Immediately after the procedure of lead removal

    Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient

  2. Detection of Agitation

    Time frame: Immediately after the procedure of lead removal

    Record of antipsychotic and anxiolytic treatment of the patient

Sponsors and collaborators

Lead sponsor

ICU Medical Technologies S.L.

Industry

Collaborators

  • Universidad Miguel Hernandez de Elche

Registry information

Acronym: TEMPACE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2022
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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