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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01100918
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have an indication for ICD therapy
2. Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction \< 35% and LV cavity dilatation (end diastolic dimension \> 55 mm)
3. NYHA Class III/IV symptoms of heart failure despite optimal medical therapy
4. QRS duration ≥120ms
Exclusion Criteria:
1. Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease
2. Requirement for ventricular pacing due to atrioventricular block.
3. Limited life expectancy (\< 6 months)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01100918
Study Brief:
Protocol Section:
NCT01100918