LifeVest Post-CABG Registry

Study Overview
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Brief Summary
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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 defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.

Official Title
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Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery

Conditions
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Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction, Myocardial Ischemia

Intervention / Treatment
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* Device: wearable defibrillator (LifeVest)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| wearable defibrillator use<br>subjects will use a wearable defibrillator | Device: wearable defibrillator (LifeVest)<br>* A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.<br>* Other names: wearable automatic external defibrillator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who experience sudden cardiac death |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who experience inappropriate shocks |  | three months | 
| hours per day of wearable defibrillator use |  | three months | 
| number of patients who experience sudden cardiac arrest |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Grafting, Resuscitation, Sudden Cardiac Death, Ventricular Dysfunction