Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT05351658
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05351658
Study Brief:
Protocol Section:
NCT05351658