Status:
TERMINATED
LifeVest Post-CABG Registry
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Sudden Cardiac Death
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01448005
Start Date
February 1 2011
End Date
October 1 2014
Last Update
December 6 2017
Active Locations (5)
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1
Sutter Heart and Vascular Institute
Sacramento, California, United States, 95819
2
Saint Joseph's Health System, Inc.
Atlanta, Georgia, United States, 30342
3
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
4
Texas Heart Institute, St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030