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Myocardial InfarctionVESTNCT01446965

Vest Prevention of Early Sudden Death Trial and VEST Registry

A study testing wearable defibrillator in people with Myocardial Infarction and Ventricular Dysfunction, run by University of California, San Francisco at 71 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
wearable defibrillator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,348 participants
Where
71 sitesin 3 countries
Study dates
Jul 2008to 31 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
  • If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
  • 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

Who cannot join

  • 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.

Trial locations and contacts

71 sites in 3 countries.

71 sites in 3 countries

United States57 sites

  • Albany Associates in Cardiology

    Albany, New York, 12205

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

  • University of Colorado

    Aurora, Colorado, 80045

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Western Kentucky Heart and Lung

    Bowling Green, Kentucky, 42101

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • University of North Carolina @ Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Providence/South Carolina Heart Center

    Columbia, South Carolina, 29204

  • University Hospital Case Medical Center

    Columbus, Ohio, 44106

  • Baylor University Medical Center

    Dallas, Texas, 75226

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Heart Institute

    Danville, Pennsylvania, 17822

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • North Ohio Heart Center-North Ohio Research

    Elyria, Ohio, 44035

  • The Heart Group/Deaconess Hospital

    Evansville, Indiana, 47713

  • McLeod Health/Pee Dee Cardiology

    Florence, South Carolina, 29506

  • Cardiovascular Consultants Heart Center

    Fresno, California, 93720

  • University of Florida

    Gainesville, Florida, 32610

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Indiana University

    Indianapolis, Indiana, 46202

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46260

  • United Health Services

    Johnson City, New York, 13790

  • Wellmont Holston Valley

    Kingsport, Tennessee, 37660

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • Watson Clinic for Research, Inc.

    Lakeland, Florida, 33805

  • University of Kentucky Gill Heart Institute

    Lexington, Kentucky, 40536

  • Melbourne Cardiac Resarch Institute

    Melbourne, Florida, 32901

  • Long Island Jewish Hospital

    New Hyde Park, New York, 11040

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • St. Luke's- Roosevelt Hospital Center

    New York, New York, 10025

  • Mount Sinai Hospital

    New York, New York, 10029

  • Lenox Hill Hospital

    New York, New York, 10075

  • Huntington Hospital

    New York, New York, 11743

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Advocate Christ Hospital

    Oak Lawn, Illinois, 60453

  • Florida Heart Group/Florida Hospital

    Orlando, Florida, 32803

  • Lutheran General

    Park Ridge, Illinois, 60068

  • Brown Medical School-Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Wake Heart Research

    Raleigh, North Carolina, 27610

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • University Cardiovascular Associates (Rochester)

    Rochester, New York, 14626

  • Salinas Valley Memorial Healthcare System

    Salinas, California, 93901

  • University of California, San Francisco

    San Francisco, California, 94143

  • The Guthrie Clinic/Guthrie Medical Group

    Sayre, Pennsylvania, 18840

  • Oregon Heart & Vascular

    Springfield, Oregon, 97477

  • Stony Brook University

    Stony Brook, New York, 11794

  • Cardiac Study Center

    Tacoma, Washington, 98405

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Cardiovascular Research Center, LLC/Mercy St Vincent

    Toledo, Ohio, 43608

  • Oklahoma Heart Institute-Hillcrest

    Tulsa, Oklahoma, 74104

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Memorial

    Worcester, Massachusetts, 01655

Other trials in United States

Germany7 sites

  • Klinikum Links der Weser gGmbh Klinik

    Bremen, 28277

  • Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus

    Duisburg, North Rhine-Westphalia, 47169

  • Klinikum Göttingen Georg-August-Universität Göttingen

    Göttingen, 37099

  • Med. Uniklinik Heidelberg

    Heidelberg, Deutschland, 69120

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063

  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Mannheim

    Mannheim, 68167

Other trials in Germany

Poland7 sites

  • Gdanski Uniwersytet Medyczny

    Gdansk, 80-952

  • Specjalistyczna Poradnia Kardiologiczna

    Kielce, 25525

  • Mc Tronik

    Lodz, 90-553

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie

    Rzeszów, 35111

  • II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)

    Warsaw, 02-637

  • Medical University of Warsaw

    Warsaw, 02097

  • Institute of Cardiology

    Warsaw, 04627

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
wearable defibrillator
Keywords
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
Medical subject headings
Myocardial Infarction, Ventricular Dysfunction, Death, Sudden, Tachycardia, Ventricular, Ventricular Fibrillation, Death, Sudden, Cardiac, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wearable defibrillatorDevice

    Also called LifeVest, wearable cardioverter-defibrillator, WCD, WD

    LifeVest wearable defibrillator

Study groups in NCT01446965
Study groupRoleWhat they receive
Wearable defibrillatorExperimentalsubjects 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
Receives: Device: wearable defibrillator
Conventional treatmentNo interventionsubjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: three months after myocardial infarction

Secondary outcomes (2)

  1. All Cause Mortality

    All deaths, due to any cause

    Measured: three months after myocardial infarction

  2. Compliance With Wearable Defibrillator Use

    daily wear time of the device

    Measured: three months after myocardial infarction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2011 (estimated)
  2. Study startJul 2008
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01446965
Sponsor's protocol ID
90D0114
Acronym
VEST
Status last verified
Dec 2020
First submitted
3 Oct 2011
Last updated
20 Jan 2021
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 30280654

Questions about this trial

What is this clinical trial studying?

A study testing wearable defibrillator in people with Myocardial Infarction and Ventricular Dysfunction, run by University of California, San Francisco at 71 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sudden Death Mortality (time frame: three months after myocardial infarction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446965, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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