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

This study is ongoing, but not recruiting participants.
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 14, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: 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:


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

Primary Outcome Measures:
  • Sudden death mortality [ Time Frame: three months after myocardial infarction ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2300
Study Start Date: July 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965

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

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 14, 2017

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

ClinicalTrials.gov processed this record on May 24, 2017