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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT05966168
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18
* Written informed consent
* Presence of a Micra AV leadless pacemaker with the Micra AV 2.0 algorithm and at least 50% RV pacing
* High grade atrioventricular heart block as the primary indication for permanent pacing
* Sinus rhythm
* Physical ability to walk on a treadmill or ride a recumbent bicycle for exercise testing
Exclusion Criteria:
* Earlier version of the Micra leadless pacemaker
* Intact atrioventricular conduction
* Persistent atrial fibrillation
* Those with absolute contraindications to exercise testing:
* Acute myocardial infarction (MI) within 2 days
* Ongoing unstable angina
* Uncontrolled cardiac arrhythmia with hemodynamic compromise
* Active endocarditis
* Symptomatic severe aortic stenosis
* Decompensated heart failure
* Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
* Acute myocarditis or pericarditis
* Acute aortic dissection
* Physical disability that precludes safe and adequate testing
* Inability to consent
* Patient refusal to participate
* Pregnant patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05966168
Study Brief:
Protocol Section:
NCT05966168