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:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00376532
Eligibility Criteria:
Inclusion Criteria:
* LVEF of ≤ 35% measured within 6 months of ICD implantation
* NYHA class II-IV at the time of ICD implantation
* ICD implantation at least 1 year prior to enrollment
Exclusion Criteria:
* Status post heart transplant
* Known malignancy in the past 2 years.
* Recent procedure, intervention or surgery within the past 90 days
* Acute MI, CABG, or PTCA/stent within the past 2 months.
* Active rheumatoid arthritis or pulmonary or hepatic fibrosis.
* Taking chronic steroid therapy for a medical condition
* Currently pregnant
* Enrolled in a concurrent study that may confound the results of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00376532
Study Brief:
Protocol Section:
NCT00376532