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Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST)

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.
 
ClinicalTrials.gov Identifier: NCT01446965
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Ventricular Dysfunction Sudden Death Ventricular Tachycardia Ventricular Fibrillation Device: wearable defibrillator Not Applicable

Detailed Description:
In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)
Actual Study Start Date : July 2008
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: Wearable defibrillator
subjects in the Device Group will receive a wearable cardioverter-defibrillator plus guideline-directed medical therapy
 Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
  • LifeVest
  • wearable cardioverter-defibrillator
  • WCD
  • WD
No Intervention: Conventional treatment
subjects in the Control Group will receive guideline-directed medical therapy alone


Outcome Measures
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Primary Outcome Measures :
  1. Sudden death mortality [ Time Frame: three months after myocardial infarction ]
    For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.


Secondary Outcome Measures :
  1. Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ]
    All deaths, due to any cause

  2. incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ]
    Evidence of new or worsening symptoms or physical examination signs of ventricular arrhythmia based on one or more of the following: a direct review of the ECG tracing, a documented electrical or pharmacologic cardioversion attempt, the initiation or elevation of the dose of a medication or the implantation of a device for the purpose of controlling the arrhythmia or complications of the arrhythmia.

  3. adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
    any undesirable sign, symptom or medical condition occurring after initiation of the study treatment that is considered to be related to study treatment

  4. compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
    daily wear time of the device


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)

  • LV ejection fraction ≤35% determined at the following time point:

    1. If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
    2. If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
    3. If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG
  • Age ≥ 18 years

Exclusion Criteria:

  • Existing ICD or indication for an ICD at the time of screening
  • Existing unipolar pacemakers/leads
  • Chronic renal failure requiring hemodialysis after hospital discharge
  • Chest circumference too small or too large for LifeVest garment*
  • Participants discharged to an institutional setting with an anticipated stay > 7 days
  • Pregnancy
  • Inability to consent
  • Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.
Contacts and Locations
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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): NCT01446965


Locations
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Sponsors and Collaborators
University of California, San Francisco
Zoll Medical Corporation
Investigators
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Principal Investigator: Jeffrey E Olgin, MD University of California, San Francisco
Study Director: Byron K Lee, MD University of California, San Francisco
Principal Investigator: Mark J Pletcher, MD, MPH University of California, San Francisco
More Information
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Additional Information:
Linked to VEST/PREDICTS registration: NCT00628966  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01446965    
Other Study ID Numbers: 90D0114
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Keywords provided by University of California, San Francisco:
myocardial infarction, acute
myocardial infarction
ventricular dysfunction
death, sudden, cardiac
death, sudden
death
 ventricular tachycardia
ventricular fibrillation
defibrillation, electric
cardioversion, electric
electric countershock
defibrillators, external
Additional relevant MeSH terms:
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Myocardial Infarction
Tachycardia
Tachycardia, Ventricular
Ventricular Dysfunction
Ventricular Fibrillation
Infarction
Death
Death, Sudden
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease