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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT04334018
Eligibility Criteria:
Inclusion Criteria:
* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months
Exclusion Criteria:
* \< 18 years and younger
* Pregnant or breastfeeding patients
* Non-LBBB patients (RBBB, intra-ventricular delay)
* Non-ambulatory NYHA class IV effort tolerance
* Myocardial infarction within 40 days before enrolment
* Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
* Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
* Patients with life expectancy of less than 12 months due to other medical conditions
* Patients who are involved in another investigational study (device or medical)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04334018
Study Brief:
Protocol Section:
NCT04334018