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

ICU Medical Technologies

Status

Completed

Conditions

Bradycardia

Arrythmia

Treatments

Device: KronoSafe® System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05351658

TEMPACE

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.