LifeVest Post-CABG Registry

This study has been terminated.
Information provided by (Responsible Party):
Zoll Medical Corporation Identifier:
First received: October 4, 2011
Last updated: December 12, 2014
Last verified: December 2014
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.

Condition Intervention
Sudden Cardiac Death
Ventricular Fibrillation
Ventricular Tachycardia
Ventricular Dysfunction
Myocardial Ischemia
Device: wearable defibrillator (LifeVest)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery

Resource links provided by NLM:

Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • number of patients who experience sudden cardiac death [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of patients who experience inappropriate shocks [ Time Frame: three months ] [ Designated as safety issue: Yes ]
  • hours per day of wearable defibrillator use [ Time Frame: three months ] [ Designated as safety issue: No ]
  • number of patients who experience sudden cardiac arrest [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: February 2011
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01448005

United States, California
Sutter Heart and Vascular Institute
Sacramento, California, United States, 95819
United States, Georgia
Saint Joseph's Health System, Inc.
Atlanta, Georgia, United States, 30342
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Texas
Texas Heart Institute, St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
United States, Virginia
Chippenham Johnston-Willis Medical Center
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
Zoll Medical Corporation
Study Director: Steven J Szymkiewicz, MD Zoll Medical Corporation
  More Information

No publications provided

Responsible Party: Zoll Medical Corporation Identifier: NCT01448005     History of Changes
Other Study ID Numbers: 90D0107
Study First Received: October 4, 2011
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zoll Medical Corporation:
Coronary Artery Bypass Grafting
Sudden Cardiac Death
Ventricular Dysfunction

Additional relevant MeSH terms:
Coronary Artery Disease
Death, Sudden, Cardiac
Myocardial Ischemia
Tachycardia, Ventricular
Ventricular Dysfunction
Ventricular Fibrillation
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes
Vascular Diseases processed this record on November 24, 2015