Vest Prevention of Early Sudden Death Trial and VEST Registry
NCT ID: NCT01446965
Last Updated: 2021-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2348 participants
INTERVENTIONAL
2008-07-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
wearable defibrillator
LifeVest wearable defibrillator
Conventional treatment
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
No interventions assigned to this group
Interventions
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wearable defibrillator
LifeVest wearable defibrillator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jeffrey E Olgin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Byron K Lee, MD
Role: STUDY_DIRECTOR
University of California, San Francisco
Mark J Pletcher, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Alaska Heart Institute
Anchorage, Alaska, United States
Cardiovascular Consultants Heart Center
Fresno, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
University of Florida
Gainesville, Florida, United States
Watson Clinic for Research, Inc.
Lakeland, Florida, United States
Melbourne Cardiac Resarch Institute
Melbourne, Florida, United States
Florida Heart Group/Florida Hospital
Orlando, Florida, United States
Advocate Christ Hospital
Oak Lawn, Illinois, United States
Lutheran General
Park Ridge, Illinois, United States
The Heart Group/Deaconess Hospital
Evansville, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
Western Kentucky Heart and Lung
Bowling Green, Kentucky, United States
University of Kentucky Gill Heart Institute
Lexington, Kentucky, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial
Worcester, Massachusetts, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
Albany Associates in Cardiology
Albany, New York, United States
United Health Services
Johnson City, New York, United States
Long Island Jewish Hospital
New Hyde Park, New York, United States
St. Luke's- Roosevelt Hospital Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Huntington Hospital
New York, New York, United States
University Cardiovascular Associates (Rochester)
Rochester, New York, United States
Stony Brook University
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina @ Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Heart Research
Raleigh, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospital Case Medical Center
Columbus, Ohio, United States
North Ohio Heart Center-North Ohio Research
Elyria, Ohio, United States
Cardiovascular Research Center, LLC/Mercy St Vincent
Toledo, Ohio, United States
Oklahoma Heart Institute-Hillcrest
Tulsa, Oklahoma, United States
Oregon Heart & Vascular
Springfield, Oregon, United States
Chambersburg Hospital
Chambersburg, Pennsylvania, United States
Geisinger Heart Institute
Danville, Pennsylvania, United States
The Guthrie Clinic/Guthrie Medical Group
Sayre, Pennsylvania, United States
Brown Medical School-Rhode Island Hospital
Providence, Rhode Island, United States
Providence/South Carolina Heart Center
Columbia, South Carolina, United States
McLeod Health/Pee Dee Cardiology
Florence, South Carolina, United States
Wellmont Holston Valley
Kingsport, Tennessee, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Cardiac Study Center
Tacoma, Washington, United States
Med. Uniklinik Heidelberg
Heidelberg, Deutschland, Germany
Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus
Duisburg, North Rhine-Westphalia, Germany
Klinikum Links der Weser gGmbh Klinik
Bremen, , Germany
Klinikum Göttingen Georg-August-Universität Göttingen
Göttingen, , Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, , Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Gdanski Uniwersytet Medyczny
Gdansk, , Poland
Specjalistyczna Poradnia Kardiologiczna
Kielce, , Poland
Mc Tronik
Lodz, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie
Rzeszów, , Poland
II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)
Warsaw, , Poland
Medical University of Warsaw
Warsaw, , Poland
Institute of Cardiology
Warsaw, , Poland
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Linked to VEST/PREDICTS registration: NCT00628966
Other Identifiers
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90D0114
Identifier Type: -
Identifier Source: org_study_id
NCT00628966
Identifier Type: -
Identifier Source: nct_alias
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