LifeVest Post-CABG Registry

Stopped early

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

In brief

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.

Key facts

Study ID

NCT01448005

Run by

Zoll Medical Corporation

People needed

69

Starts

2011-02-01

Expected to finish

2014-10-01

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Chippenham Johnston-Willis Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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