NCT05351658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

March 28, 2022

Last Update Submit

April 16, 2025

Conditions

ArrythmiaBradycardia

Keywords

PacemakerCardiac pacingBradycardiaArrhythmiaTreatment outcome

Outcome Measures

Primary Outcomes (57)

  • 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 Outcomes (2)

  • Detection of Bacteremia

    Immediately after the procedure of lead removal

  • Detection of Agitation

    Immediately after the procedure of lead removal

Study Arms (1)

Temporary Cardiac Pacing with Active-Fixation Leads

EXPERIMENTAL
Device: KronoSafe® System

Interventions

KronoSafe® SystemDEVICE

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

Temporary Cardiac Pacing with Active-Fixation Leads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital General Universitario de Alicante Dr.Balmis

Alicante, 03010, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Related Publications (5)

  • 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.

    PMID: 34918044RESULT

  • 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.

    PMID: 16580542RESULT

  • 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.

    PMID: 23482613RESULT

  • 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.

    PMID: 12954959RESULT

  • 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 Multi-Center Prospective Study. Eur Heart J Acute Cardiovasc Care. 2025 Aug 28:zuaf111. doi: 10.1093/ehjacc/zuaf111. Online ahead of print.

    PMID: 40875828DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacBradycardia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raimundo Vicente, MD

    Intensive Care Physician at Dr. Balmis University Hospital (Alicante)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 28, 2022

Study Start

January 5, 2023

Primary Completion

November 18, 2024

Study Completion

December 31, 2024

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)