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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
  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:


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
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

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

  Hide Study Locations
Locations
United States, Alaska
Alaska Heart Institute Terminated
Anchorage, Alaska, United States, 99508
United States, California
Cardiovascular Consultants Heart Center Recruiting
Fresno, California, United States, 93720
Contact: Tonya Reavis    559-432-4303 ext 7229    tonya.reavis@cvchc.com   
Contact: Mai Vang    559-432-4303 ext 8280    mvang@cvchc.com   
Principal Investigator: Michael Gen, MD         
Salinas Valley Memorial Healthcare System Terminated
Salinas, California, United States, 93901
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sarahmay Sanchez    415-514-0504    ssanchez@medicine.ucsf.edu   
Contact: Kourtney Imburgia    (415) 502-0938    kimburgia@medicine.ucsf.edu   
Principal Investigator: Greg Marcus, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Heather Maurer    303-724-6473    HEATHER.MAURER@UCDENVER.EDU   
Contact: Christina Schmitt    303-724-2098    Christina.Schmitt@ucdenver.edu   
Principal Investigator: William Sauer, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Arben Ademi    860-545-3561    Arben.Ademi@hhchealth.org   
Principal Investigator: Steven L Zweibel, MD         
United States, Delaware
Christiana Care Health Services Active, not recruiting
Newark, Delaware, United States, 19718
United States, Florida
University of Florida Recruiting
Gainsville, Florida, United States, 32610
Contact: Dana Leach    352-273-8930    dana.leach@medicine.ufl.edu   
Contact: Sarah Long    352-273-8932    Sarah.Long@medicine.ufl.edu   
Principal Investigator: William Miles, MD         
Watson Clinic for Research, Inc. Recruiting
Lakeland, Florida, United States, 33805
Contact: Noreen McGowan    866-688-6826    NMcgowan@watsonclinic.com   
Principal Investigator: Neal G Kavesh, MD         
Melbourne Cardiac Resarch Institute Terminated
Melbourne, Florida, United States, 32901
Florida Heart Group/Florida Hospital Terminated
Orlando, Florida, United States, 32803
United States, Illinois
Advocate Christ Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Diane Braun    708-684-4209    diane.braun@advocatehealth.com   
Principal Investigator: Manoj Duggal, MD         
Lutheran General Suspended
Park Ridge, Illinois, United States, 60068
United States, Indiana
The Heart Group/Deaconess Hospital Terminated
Evansville, Indiana, United States, 47713
United States, Kentucky
Western Kentucky Heart and Lung Terminated
Bowling Green, Kentucky, United States, 42101
University of Kentucky Gill Heart Institute Recruiting
Lexington, Kentucky, United States, 40536
Contact: Yvonne Taul, RN    859-218-1644    Yvonne.Taul@uky.edu   
Contact: Caroline Rodgers    859-323-1082    Caroline.rodgers@uky.edu   
Principal Investigator: Samy-Claude Elayi, MD         
United States, Louisiana
Ochsner Clinic Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cristine Hardy    504-842-6832    chardy@ochsner.org   
Principal Investigator: Daniel Morin, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Deborah Manuelian    617-732-5087    DMANUELIAN@PARTNERS.ORG   
Principal Investigator: Bruce Koplan, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Carly Crocker    617-643-1452    cacrocker@partners.org   
Principal Investigator: Theofanie Mela, MD         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Melanie Marshall    617-636-5938    mmarshall@tuftsmedicalcenter.org   
Contact: Laurie Butts    617-636-5938    Lbutts@tuftsmedicalcenter.org   
Principal Investigator: Jonathan Weinstock, MD         
University of Massachusetts Memorial Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Lori Thompson    508-856-5130    Lori.Thompson@UmassMed.edu.edu   
Contact: Alex Agrillo    (508) 856-2375    Alexandra.Agrillo@umassmed.edu   
Principal Investigator: Lawrence Rosenthal, MD         
United States, New Jersey
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Kimberly Michel    201-447-8000 ext 2745    kmichel@valleyhealth.com   
Principal Investigator: Gerald Sotsky, MD         
United States, New Mexico
Presbyterian Heart Group Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Rae Woods    505-563-2716    rwoods@phs.org   
Contact: Susan Salazar    505-563-2716    ssalazar2@phs.org   
Principal Investigator: Lawrence Nair, MD         
United States, New York
Albany Associates in Cardiology Recruiting
Albany, New York, United States, 12205
Contact: PeggySue Schaumann-Boyle    518-435-2758    peggy.schaummann-boyle@sphp.com   
Contact: Elizabeth (Betty) Bursey    (518)435-2759    elizabeth.bursey@sphp.com   
Principal Investigator: Robert S. Phang, MD         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Jessica Rodriguez    718-920-5733    jessirod@montefiore.org   
Contact: Marshalee Mcintosh    718-904-2067    MAMCINTO@montefiore.org   
Principal Investigator: Jay Gross, MD         
United Health Services Active, not recruiting
Johnson City, New York, United States, 13790
Long Island Jewish Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Denise McDermott    718-470-7736    DMcDermo@NSHS.edu   
Contact: Marisa Kavanaugh-Hogans    (718)470-4257    Mkavanaugh@NSHS.edu   
Principal Investigator: David Slotwiner, MD         
Huntington Hospital Recruiting
New York, New York, United States, 11743
Contact: Dana Kuziw    631-547-7191    dkuziw@hunthosp.org   
Principal Investigator: Paul Maccaro, MD         
Mount Sinai Hospital Terminated
New York, New York, United States, 10029
St. Luke's- Roosevelt Hospital Center Recruiting
New York, New York, United States, 10025
Contact: Ammy Malinay    212-523-3281    aalburo@chpnet.org   
Principal Investigator: Emad Aziz         
Lenox Hill Hospital Recruiting
New York City, New York, United States, 10075
Contact: Miriam Lucca-Susana    212-434-3734    Mluccasusa@NSHS.edu   
Principal Investigator: Nicholas Skipitaris, MD         
University Cardiovascular Associates (Rochester) Terminated
Rochester, New York, United States, 14626
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Maria Amella    631-444-8485    Maria.Amella@stonybrook.edu   
Contact: Mary Sophy Yohannan    631 444 8417    Mary.Yohanna@stonybrookmedicine.edu   
Principal Investigator: Eric Rashba, MD         
United States, North Carolina
University of North Carolina @ Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Amy Que-Xu    919-843-4597    amy_que-xu@med.unc.edu   
Contact: Tyrone Wade    919-962-4896    tywade01@email.unc.edu   
Principal Investigator: Paul Mounsey, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Anthony Waldron, Jr    919-681-9772    anthony.waldronjr@duke.edu   
Contact: Deborah Hickey    919-668-3524    deborah.hickey@duke.edu   
Principal Investigator: Donald Hegland, MD         
Wake Heart Research Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Hailey Kessler    919-231-8253 ext 3181    hkessler@nchvresearch.com   
Contact: Meredith Shillinglaw    919-231-8253 ext 3127    mshillinglaw@nchvresearch.com   
Principal Investigator: Robert L Jobe         
Wake Forest University Health Sciences Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Malissa Tickle    336-716-5865    mtickle@wakehealth.edu   
Principal Investigator: Tony W. Simmons, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Melanie Panko, RN, BSN    216-444-6478    PANKOM@ccf.org   
Contact: Kathy Sankovic    216-445-6916    SANKOVK@ccf.org   
Principal Investigator: Mina Chung         
University Hospital Case Medical Center Recruiting
Columbus, Ohio, United States, 44106
Contact: Maria Scheutzow    216-286-6550    Maria.Scheutzow@UHhospitals.org   
Principal Investigator: Mauricio Arruda, MD         
North Ohio Heart Center-North Ohio Research Recruiting
Elyria, Ohio, United States, 44035
Contact: Darlene Carr    440-366-2264    dcarr@nohc.com   
Principal Investigator: Kara Quan, MD         
Cardiovascular Research Center, LLC/Mercy St Vincent Terminated
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma Heart Institute-Hillcrest Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Jolene Durham    918-579-4939    Jolene.Durham@ardenthealth.com   
Contact: Clarissa Wheeler    918-579-5865    Clarissa.Wheeler@hillcrest.com   
Principal Investigator: David A. Sandler, MD         
United States, Oregon
Oregon Heart & Vascular Terminated
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Chambersburg Hospital Recruiting
Chambersburg, Pennsylvania, United States, 17201
Contact: Cindy Green    717-267-4880    cgreen@summithealth.org   
Contact: Jacklyn Newell    717-262-4697    JNEWELL@summithealth.org   
Principal Investigator: Aylmer Tang, MD         
Geisinger Heart Institute Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Marilee Manganiello    570-808-6123    mfmanganiello@geisinger.edu   
Contact: Kay Blyler    570.214.5421    kmblyler@geisinger.edu   
Principal Investigator: Gopi Dandamudi, MD         
United States, Rhode Island
Brown Medical School-Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kelly Franchetti    401-444-8928    kfranchetti@lifespan.org   
Contact: Cathy Gordon    401-444-8928    cgordan@lifespan.org   
Principal Investigator: Peem Lorvidhaya, MD         
United States, South Carolina
Providence/South Carolina Heart Center Recruiting
Columbia, South Carolina, United States, 29204
Contact: Kelly Crump, RN    803-255-2927    Kcrump@scheart.com   
Principal Investigator: Venkateshwar Gottipaty, MD         
McLeod Health/Pee Dee Cardiology Recruiting
Florence, South Carolina, United States, 29506
Contact: Rhonda Johnson    843-667-1891 ext 8465    rjohnson@mcleodhealth.org   
Principal Investigator: Rajesh Malik, MD         
United States, Tennessee
Wellmont Holston Valley Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Ashley Sparks, LVN, CRC    423-230-5062    asparks@mycva.com   
Principal Investigator: Gregory Jones, MD         
Turkey Creek Medical Center Terminated
Knoxville, Tennessee, United States, 37934
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75226
Contact: Jenny Cruthis    214-820-3319    jenncru@baylorhealth.edu   
Principal Investigator: Jay Franklin, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Anne Leyretana-Zabat    214-590-5015    Anne.Leyretana-Zabat@UTSouthwestern.edu   
Principal Investigator: Richard Wu, MD         
United States, Virginia
Carilion Clinic Recruiting
Roanoke, Virginia, United States, 24014
Contact: Lisa Wilkerson    540-266-6658    ljwilkerson@carilionclinic.org   
Contact: Karen Buchanan, BSN, RN    540 981 7493    kdbuchanan@carilionclinic.org   
Principal Investigator: Soufian Almahameed, MD         
United States, Washington
Cardiac Study Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Kathy Marks    253-572-7320 ext 3030    kathymarks@cardiacstudycenter.com   
Contact: Alison Swarens    253-403-1707    Alison.Swarens@multicare.org   
Principal Investigator: Tariq Salam, MD         
Germany
Med. Uniklinik Heidelberg Recruiting
Heidelberg, Deutschland, Germany, 69120
Contact: Sonja Tran    49062115637124    sonja.tran@med.uni-heidelberg.de   
Principal Investigator: Dierk Thomas, MD         
Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus Recruiting
Duisburg, Nordrhein-Westfalen, Germany, 47169
Contact: Dunja Schulenburg    +49(0)203 451 3509    dunja.schulenburg@evkln.de   
Principal Investigator: Wolfgang Schöls         
Klinikum Links der Weser gGmbh Klinik Recruiting
Bremen, Germany, 28277
Contact: Bettina Wuermann-Busch    49 0 421 879 1642    bettina.wuermann-busch@klinikum-bremen-ldw.de   
Principal Investigator: Rainer Hambrecht         
Klinikum Göttingen Georg-August-Universität Göttingen Recruiting
Göttingen, Germany, 37099
Contact: Stefanie Baumert    49(0)551 39 10475    baumert.ifs@med.uni-goettingen.de   
Principal Investigator: Markus Zabel         
Klinikum der Stadt Ludwigshafen Recruiting
Ludwigshafen, Germany, 67063
Contact: Petra Zaricor    49 (0) 621-503-4354    zaricorp@klilu.de   
Principal Investigator: Thomas Kleemann         
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Baerbel Kaesberger    49 6131 - 17 5828    baerbel.kaesberger@unimedizin-mainz.de   
Principal Investigator: Thomas Münzel         
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Brigitte Kircher    +49(0)621 3831490    brigitte.kircher@umm.de   
Contact: Stefanie Dorn    49 621 383 1492    Stefanie.Dorn@umm.de   
Principal Investigator: Martin Borggrefe         
Poland
Gdanski Uniwersytet Medyczny Recruiting
Gdansk, Poland, 80-952
Contact: Ewa Lewicka    48 608 670 152    elew@gumed.edu.pl   
Principal Investigator: Grzegorz Raczak         
Mc Tronik Recruiting
Lodz, Poland, 90-553
Contact: Bozena Urbanek    48 60 627 66 99    bozena_urbanek@op.pl   
Contact: Anna Nowek    +48 50 548 55 95    noweka@wp.pl   
Principal Investigator: Wranicz Jerzy Krzysztof         
II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II) Recruiting
Warsaw, Poland, 02-637
Contact: Michal Lewandowski    48 609 683 955    mlewandowski@ikard.pl   
Principal Investigator: Maciej Sterlinski         
Institute of Cardiology Recruiting
Warszawa, Poland, 04627
Contact: Artur Oreziak    48 22 343 41 86    aoreziak@ikard.pl   
Principal Investigator: Andrzej Przybylski, MD, PhD         
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: October 1, 2014
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
Tachycardia, Ventricular
Ventricular Dysfunction
Ventricular Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014