LifeVest Post-CABG Registry

Terminated

• Conditions: Ventricular Dysfunction; Myocardial Ischemia; Sudden Cardiac Death; Ventricular Tachycardia; Ventricular Fibrillation
• Interventions: Device: wearable defibrillator (LifeVest)

• Registration Number: NCT01448005
• Lead Sponsor: Zoll Medical Corporation

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
wearable defibrillator use	wearable defibrillator (LifeVest)	subjects will use a wearable defibrillator

Primary Outcome Measures

Name	Time	Method
number of patients who experience sudden cardiac death	three months

Secondary Outcome Measures

Name	Time	Method
hours per day of wearable defibrillator use	three months
number of patients who experience inappropriate shocks	three months
number of patients who experience sudden cardiac arrest	three months

Trial Locations

Locations (5)

Sutter Heart and Vascular Institute; 🇺🇸 Sacramento, California, United States

Saint Joseph's Health System, Inc.; 🇺🇸 Atlanta, Georgia, United States

Texas Heart Institute, St. Luke's Episcopal Hospital; 🇺🇸 Houston, Texas, United States

Chippenham Johnston-Willis Medical Center; 🇺🇸 Richmond, Virginia, United States

Washington Adventist Hospital; 🇺🇸 Takoma Park, Maryland, United States