LifeVest Post-CABG Registry

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

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 Overview

• Status: Terminated
• Conditions: Myocardial Ischemia; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Dysfunction; Sudden Cardiac Death
• Intervention / Treatment: Device: wearable defibrillator (LifeVest)

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Sutter Heart and Vascular Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Saint Joseph's Health System, Inc.
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Heart Institute, St. Luke's Episcopal Hospital
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Chippenham Johnston-Willis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
wearable defibrillator use; subjects will use a wearable defibrillator	Device: wearable defibrillator (LifeVest); A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.; Other Names: LifeVest; wearable cardioverter defibrillator; wearable automatic external defibrillator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Sudden Cardiac Death; Resuscitation; Ventricular Dysfunction; Coronary Artery Bypass Grafting
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Myocardial Ischemia; Ischemia; Death; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Dysfunction; Death, Sudden, Cardiac
• Other Study ID Numbers: 90D0107