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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05564793
Eligibility Criteria:
Inclusion Criteria:
1. Appropriately signed and dated informed consent.
2. Age ≥18 years at time of consent.
3. Received optimal medical therapy for HF for at least 3 months before screening
4. Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteria per ESC CRT guidelines 2013 .
5. Patient is intended for placement of a CRT device with biventricular (BiV) pacing.
Exclusion Criteria:
1. Previous cardiac pacemaker/CRT/ICD implantation
2. Acute diseases or exacerbations of chronic diseases (as per the investigator's discretion)
3. Contraindications to CT scanning
4. Contraindications to body surface ECG mapping: (ongoing wound healing on the chest (e.g. recent surgery), skin diseases, allergic reactions to surface mapping electrodes and medical band-aid)
5. Pregnant, or subjects planning to become pregnant within 6 months after signing informed consent (a documented negative pregnancy test (serum or blood) is required for women of childbearing potential)
6. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05564793
Study Brief:
Protocol Section:
NCT05564793