Vest Prevention of Early Sudden Death Trial and VEST Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01446965
First received: October 3, 2011
Last updated: October 1, 2014
Last verified: October 2014

October 3, 2011
October 1, 2014
July 2008
September 2015   (final data collection date for primary outcome measure)
Sudden death mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01446965 on ClinicalTrials.gov Archive Site
  • Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
  • incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
  • adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: Yes ]
  • compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vest Prevention of Early Sudden Death Trial and VEST Registry
Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Ventricular Dysfunction
  • Sudden Death
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
  • LifeVest
  • wearable cardioverter-defibrillator
  • WCD
  • WD
  • Experimental: Wearable defibrillator
    subjects will use a wearable defibrillator for three months following myocardial infarction
    Intervention: Device: wearable defibrillator
  • No Intervention: Conventional treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1900
September 2015
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Carol Maguire, RN 415-476-5148 cmaguire@medicine.ucsf.edu
United States,   Poland,   Germany
 
NCT01446965
90D0114
Yes
University of California, San Francisco
University of California, San Francisco
Zoll Medical Corporation
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
University of California, San Francisco
October 2014

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