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Vest Prevention of Early Sudden Death Trial and VEST Registry

This study is currently recruiting participants.
Verified April 2013 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: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarction
Ventricular Dysfunction
Sudden Death
Ventricular Tachycardia
Ventricular Fibrillation
 Device: wearable defibrillator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Sudden death mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1900
Study Start Date: July 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wearable defibrillator
subjects will use a wearable defibrillator for three months following myocardial infarction
 Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
  • LifeVest
  • wearable cardioverter-defibrillator
  • WCD
  • WD
No Intervention: Conventional treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965

Contacts
Contact: Carol Maguire, RN 415-476-5148 cmaguire@medicine.ucsf.edu

  Show 52 Study Locations
Sponsors and Collaborators
University of California, San Francisco
Zoll Medical Corporation
Investigators
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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01446965     History of Changes
Obsolete Identifiers: NCT00628966
Other Study ID Numbers: 90D0114
Study First Received: October 3, 2011
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

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:
Death
Death, Sudden
Infarction
Myocardial Infarction
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Ventricular Dysfunction
 Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on June 18, 2013