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

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ClinicalTrials.gov Identifier: NCT01446965
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 3, 2011
First Posted Date  ICMJE October 5, 2011
Results First Submitted Date  ICMJE December 4, 2020
Results First Posted Date  ICMJE January 20, 2021
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
Sudden Death Mortality [ Time Frame: three months after myocardial infarction ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
  • All Cause Mortality [ Time Frame: three months after myocardial infarction ]
    All deaths, due to any cause
  • Compliance With Wearable Defibrillator Use [ Time Frame: three months after myocardial infarction ]
    daily wear time of the device
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
  • Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ]
  • incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ]
  • adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
  • Compliance With Wearable Defibrillator Use [ Time Frame: three months after myocardial infarction ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vest Prevention of Early Sudden Death Trial and VEST Registry
Official Title  ICMJE Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Ventricular Dysfunction
  • Sudden Death
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Intervention  ICMJE Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
  • LifeVest
  • wearable cardioverter-defibrillator
  • WCD
  • WD
Study Arms  ICMJE
  • Experimental: Wearable defibrillator
    subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
    Intervention: Device: wearable defibrillator
  • No Intervention: Conventional treatment
    subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Publications * Olgin JE, Pletcher MJ, Vittinghoff E, Wranicz J, Malik R, Morin DP, Zweibel S, Buxton AE, Elayi CS, Chung EH, Rashba E, Borggrefe M, Hue TF, Maguire C, Lin F, Simon JA, Hulley S, Lee BK; VEST Investigators. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018 Sep 27;379(13):1205-1215. doi: 10.1056/NEJMoa1800781.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2020)
2348
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2011)
1900
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01446965
Other Study ID Numbers  ICMJE 90D0114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Zoll Medical Corporation
Investigators  ICMJE
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
PRS Account University of California, San Francisco
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP