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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT05015660
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Patients with an ejection fraction of \>35%
3. Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \>90% including:
1. Third degree AV block
2. Symptomatic or asymptomatic second-degree AV block
3. First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
4. Echocardiogram within the last 3 months, with ability to have DICOM images
Exclusion Criteria:
1. Indication for an implantable cardioverter defibrillator
2. Presence of a mechanical tricuspid valve
3. Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
4. Lack of capacity to consent
5. Other serious medical condition with life expectancy of \<2 years
6. Pregnancy
7. Patients in whom the conduction system abnormality is expected to be transient or recover over time
8. Patients with permanent atrial fibrillation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05015660
Study Brief:
Protocol Section:
NCT05015660