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

Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Dysfunction; Sudden Death
• Intervention / Treatment: Device: wearable defibrillator

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: Interventional
• Enrollment (Actual): 2348
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bremen, Germany, 28277
    • Klinikum Links der Weser gGmbh Klinik
  • Göttingen, Germany, 37099
    • Klinikum Göttingen Georg-August-Universität Göttingen
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Mannheim, Germany, 68167
    • Universitätsklinikum Mannheim
  • Deutschland
    • Heidelberg, Deutschland, Germany, 69120
      • Med. Uniklinik Heidelberg
  • Nordrhein-Westfalen
    • Duisburg, Nordrhein-Westfalen, Germany, 47169
      • Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus
• Poland
  • Gdansk, Poland, 80-952
    • Gdanski Uniwersytet Medyczny
  • Kielce, Poland, 25525
    • Specjalistyczna Poradnia Kardiologiczna
  • Lodz, Poland, 90-553
    • Mc Tronik
  • Rzeszow, Poland, 35111
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie
  • Warsaw, Poland, 02-637
    • II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)
  • Warsaw, Poland, 02097
    • Medical University of Warsaw
  • Warszawa, Poland, 04627
    • Institute of Cardiology
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart Institute
  • California
    • Fresno, California, United States, 93720
      • Cardiovascular Consultants Heart Center
    • Salinas, California, United States, 93901
      • Salinas Valley Memorial Healthcare System
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Lakeland, Florida, United States, 33805
      • Watson Clinic for Research, Inc.
    • Melbourne, Florida, United States, 32901
      • Melbourne Cardiac Resarch Institute
    • Orlando, Florida, United States, 32803
      • Florida Heart Group/Florida Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Hospital
    • Park Ridge, Illinois, United States, 60068
      • Lutheran General
  • Indiana
    • Evansville, Indiana, United States, 47713
      • The Heart Group/Deaconess Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Medical Group
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Western Kentucky Heart And Lung
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Gill Heart Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Heart Group
  • New York
    • Albany, New York, United States, 12205
      • Albany Associates in Cardiology
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Johnson City, New York, United States, 13790
      • United Health Services
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10025
      • St. Luke's- Roosevelt Hospital Center
    • New York, New York, United States, 11743
      • Huntington Hospital
    • Rochester, New York, United States, 14626
      • University Cardiovascular Associates (Rochester)
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina @ Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27610
      • Wake Heart Research
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 44106
      • University Hospital Case Medical Center
    • Elyria, Ohio, United States, 44035
      • North Ohio Heart Center-North Ohio Research
    • Toledo, Ohio, United States, 43608
      • Cardiovascular Research Center, LLC/Mercy St Vincent
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute-Hillcrest
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Heart & Vascular
  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
      • Chambersburg Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Heart Institute
    • Sayre, Pennsylvania, United States, 18840
      • The Guthrie Clinic/Guthrie Medical Group
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown Medical School-Rhode Island Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Providence/South Carolina Heart Center
    • Florence, South Carolina, United States, 29506
      • McLeod Health/Pee Dee Cardiology
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75226
      • Baylor University Medical Center
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic
  • Washington
    • Tacoma, Washington, United States, 98405
      • Cardiac Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: wearable defibrillator; LifeVest wearable defibrillator; Other Names: WCD; LifeVest; wearable cardioverter-defibrillator; WD
NO_INTERVENTION: Conventional treatment; subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sudden Death Mortality	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.	three months after myocardial infarction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Mortality	All deaths, due to any cause	three months after myocardial infarction
Compliance With Wearable Defibrillator Use	daily wear time of the device	three months after myocardial infarction

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Zoll Medical Corporation
• Investigators: Study Director: Byron K Lee, MD, University of California, San Francisco; Principal Investigator: Mark J Pletcher, MD, MPH, University of California, San Francisco

Publications and helpful links

General 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.

Helpful Links

• Linked to VEST/PREDICTS registration: NCT00628966

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2008
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (ESTIMATE): October 5, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: myocardial infarction; ventricular tachycardia; ventricular fibrillation; ventricular dysfunction; death; death, sudden; myocardial infarction, acute; death, sudden, cardiac; defibrillation, electric; cardioversion, electric; electric countershock; defibrillators, external
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Myocardial Infarction; Infarction; Death; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Dysfunction; Death, Sudden
• Other Study ID Numbers: 90D0114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO