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Trial record 96 of 132 for:    "Paroxysmal Ventricular Fibrillation"

LifeVest Post-CABG Registry

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. Identifier: NCT01448005
Recruitment Status : Terminated (Enrollment)
First Posted : October 6, 2011
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):
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.

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

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
Study Start Date : February 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. number of patients who experience sudden cardiac death [ Time Frame: three months ]

Secondary Outcome Measures :
  1. number of patients who experience inappropriate shocks [ Time Frame: three months ]
  2. hours per day of wearable defibrillator use [ Time Frame: three months ]
  3. number of patients who experience sudden cardiac arrest [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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.

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 identifier (NCT number): NCT01448005

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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
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Study Director: Steven J Szymkiewicz, MD Zoll Medical Corporation

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Responsible Party: Zoll Medical Corporation Identifier: NCT01448005     History of Changes
Other Study ID Numbers: 90D0107
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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

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