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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT02121158
Eligibility Criteria:
Inclusion Criteria:
1. 70 years of age or older
2. Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:
1. Documented prior MI and a measured left ventricular ejection fraction (LVEF) \<=30% (includes New York Heart Association \[NYHA\] class I, II, or III)
2. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction \<=35%, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) at electrophysiology (EP) study
3. Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF \<=35%
4. Non-ischemic dilated cardiomyopathy (NIDCM) \> 3 months, NYHA Class II and III heart failure, and measured LVEF \<=35%
3. Stable condition on Optimal Medical Therapy
4. Able and willing to provide informed consent to participate in this study
Exclusion Criteria:
1. Enrolled in or planning to enroll in a conflicting trial
2. Receiving a bi-ventricular ICD device
3. New York Heart Association class IV heart failure
4. Cardiogenic shock or symptomatic hypotension while in stable baseline rhythm,
5. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months
6. An MI within the past 40 days
7. Clinical symptoms or findings that would make them a candidate for coronary revascularization
8. Irreversible brain damage from pre-existing cerebral disease
9. Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year
10. Circumstance that would prevent completion of the trial and follow-up activities, including medical condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02121158
Study Brief:
Protocol Section:
NCT02121158