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:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT06100757
Eligibility Criteria:
Inclusion Criteria:
* Patients with a Class I or II indication for single chamber pacemaker following international guidelines
Exclusion Criteria:
* patients with previously implanted cardiac devices / mechanical valves that would interfere with the echocardiographic measurements
* patients with inadequate image quality at baseline that prohibited the assessment of myocardial mechanics using echocardiography
* patients with a left ventricular ejection fraction (LVEF) ≤40% at baseline
* patients considered to have a pre-existing condition challenging/precluding the implant of a conventional pacemaker
* patients who refused or were not able to provide written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06100757
Study Brief:
Protocol Section:
NCT06100757