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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT01448005
Eligibility Criteria:
Inclusion Criteria:
* Patients who have undergone CABG surgery during current hospitalization
* Patients who have an ejection fraction ≤ 35% following the surgery.
* Patients who have dilated cardiomyopathy or prior myocardial infarction.
* Patients who are prescribed a wearable defibrillator following surgery.
* Patient who are at least 18 years old.
Exclusion Criteria:
* Patients who have an active ICD.
* Patients who have an active unipolar pacemaker.
* Patients having a chest circumference over 56 inches or under 26 inches.
* Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
* Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
* Patients participating in another clinical study with mortality as the primary endpoint.
* Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
* Patients who have decided to forgo resuscitation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01448005
Study Brief:
Protocol Section:
NCT01448005