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LifeVest Post-CABG Registry

This study has been terminated.
(Enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448005
First Posted: October 6, 2011
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zoll Medical Corporation
  Purpose
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 ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448005


Locations
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
Investigators
Study Director: Steven J Szymkiewicz, MD Zoll Medical Corporation
  More Information

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT01448005     History of Changes
Other Study ID Numbers: 90D0107
First Submitted: October 4, 2011
First Posted: October 6, 2011
Last Update Posted: November 15, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Ischemia
Tachycardia
Myocardial Ischemia
Coronary Artery Disease
Ventricular Dysfunction
Tachycardia, Ventricular
Death
Death, Sudden, Cardiac
Ventricular Fibrillation
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Heart Arrest
Death, Sudden