ArrythmiaTEMPACENCT05351658
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
A study testing KronoSafe® System in people with Arrythmia and Bradycardia, run by ICU Medical Technologies S.L. at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia, Bradycardia
- What is being tested?
- KronoSafe® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital General Universitario de Alicante Dr.Balmis
Alicante, 03010
Hospital Universitari Vall D'Hebron
Barcelona, 08035
About this study
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.
- Conditions
- Arrythmia, Bradycardia
- Being tested
- KronoSafe® System
- Keywords
- Pacemaker, Cardiac pacing, Bradycardia, Arrhythmia, Treatment outcome
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KronoSafe® SystemDevice
All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.
| Study group | Role | What they receive |
|---|---|---|
| Temporary Cardiac Pacing with Active-Fixation Leads | Experimental | Not described Receives: Device: KronoSafe® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: Immediately after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: Immediately after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: Immediately after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: 24 hours after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 3 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 5 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 7 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 9 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 11 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 13 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 15 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 17 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 19 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 21 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 23 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 25 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 27 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: day 29 after the procedure of lead implantation
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Measured: Immediately before the procedure of lead removal
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: 24 hours after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 3 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 5 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 7 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 9 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 11 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 13 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 15 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 17 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 19 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 21 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 23 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 25 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 27 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: day 29 after the procedure of lead implantation
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Measured: Immediately before the procedure of lead removal
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: 24 hours after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 3 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 5 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 7 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 9 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 11 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 13 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 15 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 17 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 19 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 21 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 23 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 25 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 27 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: day 29 after the procedure of lead implantation
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Measured: Immediately before the procedure of lead removal
Lead displacement detection
Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Measured: Immediately before the procedure of lead removal
Capture failure detection
Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Measured: Immediately before the procedure of lead removal
Sensing failure detection
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Measured: Immediately before the procedure of lead removal
Lead insulation breakdown detection
Visual observation of lead insulation breakdown by clinical examination
Measured: 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.
Measured: 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%
Measured: Immediately before the procedure of lead removal
Secondary outcomes (2)
Detection of Bacteremia
Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient
Measured: Immediately after the procedure of lead removal
Detection of Agitation
Record of antipsychotic and anxiolytic treatment of the patient
Measured: Immediately after the procedure of lead removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start5 Jan 2023
- Primary completion18 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ICU Medical Technologies S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Sponsor
- Investigators
- Raimundo Vicente, MD, Principal investigator, Intensive Care Physician at Dr. Balmis University Hospital (Alicante)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351658
- Sponsor's protocol ID
- TEMPACE
- Acronym
- TEMPACE
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2022
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34918044Zei 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.
PubMed 16580542Kawata 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.
PubMed 23482613Betts 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.
PubMed 12954959Vicente-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 multicentre prospective study. Eur Heart J Acute Cardiovasc Care. 2026 Jan 23;14(12):732-738. doi: 10.1093/ehjacc/zuaf111.
PubMed 40875828
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
- ClinicalTrials.gov ID
- NCT05351658
- Acronym / sponsor ID
- TEMPACE / TEMPACE
- Conditions
- Arrythmia, Bradycardia
- Keywords
- Pacemaker, Cardiac pacing, Bradycardia, Arrhythmia, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ICU Medical Technologies S.L.Industry (pharma, biotech, devices)
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Temporary Cardiac Pacing with Active-Fixation Leads | Experimental | Device: KronoSafe® System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KronoSafe® SystemAll patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system. | Device | Temporary Cardiac Pacing with Active-Fixation Leads |
Primary outcome
Ventricular R wave detection
Time frame: Immediately after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection
Time frame: Immediately after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Right ventricle threshold detection
Time frame: Immediately after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Ventricular R wave detection
Time frame: 24 hours after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 3 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 5 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 7 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 9 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 11 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 13 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 15 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 17 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 19 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 21 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 23 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 25 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 27 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: day 29 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Time frame: Immediately before the procedure of lead removal
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection
Time frame: 24 hours after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 3 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 5 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 7 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 9 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 11 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 13 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 15 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 17 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 19 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 21 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 23 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 25 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 27 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: day 29 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Time frame: Immediately before the procedure of lead removal
Lead impedance, measured in ohms with pacemaker generator programmer
Right ventricle threshold detection
Time frame: 24 hours after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 3 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 5 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 7 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 9 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 11 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 13 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 15 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 17 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 19 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 21 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 23 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 25 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 27 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: day 29 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Time frame: Immediately before the procedure of lead removal
Right ventricle threshold, measured in volts with pacemaker generator programmer
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
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.
Sensing failure detection
Time frame: Immediately before the procedure of lead removal
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Lead insulation breakdown detection
Time frame: Immediately before the procedure of lead removal
Visual observation of lead insulation breakdown by clinical examination
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.
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%
2 secondary outcomes
Detection of Bacteremia
Time frame: Immediately after the procedure of lead removal
Detection of Agitation
Time frame: Immediately after the procedure of lead removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Results publication: PubMed 34918044Vicente-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.
- Results publication: PubMed 16580542Zei 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.
- Results publication: PubMed 23482613Kawata 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.
- Results publication: PubMed 12954959Betts 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.
- Derived from this study: PubMed 40875828Vicente-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 multicentre prospective study. Eur Heart J Acute Cardiovasc Care. 2026 Jan 23;14(12):732-738. doi: 10.1093/ehjacc/zuaf111.
- Individual participant dataSharing planned: No
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Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raimundo Vicente, MD principal investigator
Intensive Care Physician at Dr. Balmis University Hospital (Alicante)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KronoSafe® System in people with Arrythmia and Bradycardia, run by ICU Medical Technologies S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular R wave detection (time frame: Immediately after the procedure of lead implantation). The study lists 57 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351658, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.