LifeVest Post-CABG Registry

Zoll Medical Corporation69 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sudden Cardiac Death Ventricular Fibrillation Ventricular Tachycardia Ventricular Dysfunction Myocardial Ischemia

Interventions

wearable defibrillator (LifeVest)DEVICE

A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Sutter Heart and Vascular Institute

Sacramento, California, United States

Saint Joseph's Health System, Inc.

Atlanta, Georgia, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Texas Heart Institute, St. Luke's Episcopal Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

number of patients who experience sudden cardiac death

Time frame: three months

Secondary Outcomes

number of patients who experience inappropriate shocks

Time frame: three months

hours per day of wearable defibrillator use

Time frame: three months

number of patients who experience sudden cardiac arrest

Time frame: three months

Data from ClinicalTrials.gov

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