CompletedNot Applicable

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

Spain30 participantsStarted 2023-01-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ventricular R wave detection

Timeframe: Immediately after the procedure of lead implantation

Lead impedance detection

Timeframe: Immediately after the procedure of lead implantation

Right ventricle threshold detection

Timeframe: Immediately after the procedure of lead implantation

Ventricular R wave detection

Timeframe: 24 hours after the procedure of lead implantation

Ventricular R wave detection

Timeframe: day 3 after the procedure of lead implantation

Ventricular R wave detection

Timeframe: day 5 after the procedure of lead implantation

Ventricular R wave detection

Timeframe: day 7 after the procedure of lead implantation

Trial details

NCT IDNCT05351658

SponsorICU Medical Technologies S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-18

View on ClinicalTrials.gov More Arrythmia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ventricular R wave detection

Timeframe: Immediately after the procedure of lead implantation

Lead impedance detection

Timeframe: Immediately after the procedure of lead implantation

Right ventricle threshold detection

Timeframe: Immediately after the procedure of lead implantation

Ventricular R wave detection

Timeframe: 24 hours after the procedure of lead implantation

Ventricular R wave detection

Timeframe: day 3 after the procedure of lead implantation

Ventricular R wave detection

Timeframe: day 5 after the procedure of lead implantation

Ventricular R wave detection

Timeframe: day 7 after the procedure of lead implantation