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

December 30, 2020 updated by: University of California, San Francisco

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Gdański 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sudden Death Mortality
Time Frame: three months after myocardial infarction
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All Cause Mortality
Time Frame: three months after myocardial infarction
All deaths, due to any cause
three months after myocardial infarction
Compliance With Wearable Defibrillator Use
Time Frame: three months after myocardial infarction
daily wear time of the device
three months after myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zoll Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90D0114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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