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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01076660
Eligibility Criteria:
Inclusion Criteria:
* LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
* Between the ages of 21 and 80 years old
* Permission of the patient's clinical attending physician
Exclusion Criteria:
* Patients who refuse or are unable to give consent.
* Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
* Minors.
* Pregnant women.
* NYHA Class IV heart failure.
* Chronic renal insufficiency with creatinine clearance\<60 ml/min; acute renal insufficiency of any severity
* Claustrophobia
* Prior adverse reaction to gadolinium-based contrast
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT01076660
Study Brief:
Protocol Section:
NCT01076660