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 range18 Years

SexALL

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.

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

Ventricular R wave detection

Timeframe: day 9 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 range18 Years

SexALL

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

Ventricular R wave detection

Timeframe: day 9 after the procedure of lead implantation