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

Primary Purpose

Myocardial Infarction, Ventricular Dysfunction, Sudden Death

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
wearable defibrillator
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alaska Heart Institute
  • Cardiovascular Consultants Heart Center
  • Salinas Valley Memorial Healthcare System
  • University of California, San Francisco
  • University of Colorado
  • Hartford Hospital
  • Christiana Care Health Services
  • University of Florida
  • Watson Clinic for Research, Inc.
  • Melbourne Cardiac Resarch Institute
  • Florida Heart Group/Florida Hospital
  • Advocate Christ Hospital
  • Lutheran General
  • The Heart Group/Deaconess Hospital
  • Indiana University
  • St. Vincent Medical Group
  • Western Kentucky Heart and Lung
  • University of Kentucky Gill Heart Institute
  • Ochsner Clinic
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • University of Massachusetts Memorial
  • The Valley Hospital
  • Presbyterian Heart Group
  • Albany Associates in Cardiology
  • Montefiore Medical Center
  • United Health Services
  • Long Island Jewish Hospital
  • St. Luke's- Roosevelt Hospital Center
  • Mount Sinai Hospital
  • Lenox Hill Hospital
  • Huntington Hospital
  • University Cardiovascular Associates (Rochester)
  • Stony Brook University
  • University of North Carolina @ Chapel Hill
  • Duke University Medical Center
  • Wake Heart Research
  • Wake Forest University Health Sciences
  • Cleveland Clinic
  • University Hospital Case Medical Center
  • North Ohio Heart Center-North Ohio Research
  • Cardiovascular Research Center, LLC/Mercy St Vincent
  • Oklahoma Heart Institute-Hillcrest
  • Oregon Heart & Vascular
  • Chambersburg Hospital
  • Geisinger Heart Institute
  • The Guthrie Clinic/Guthrie Medical Group
  • Brown Medical School-Rhode Island Hospital
  • Providence/South Carolina Heart Center
  • McLeod Health/Pee Dee Cardiology
  • Wellmont Holston Valley
  • Turkey Creek Medical Center
  • Baylor University Medical Center
  • University of Texas Southwestern Medical Center
  • Carilion Clinic
  • Cardiac Study Center
  • Med. Uniklinik Heidelberg
  • Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus
  • Klinikum Links der Weser gGmbh Klinik
  • Klinikum Göttingen Georg-August-Universität Göttingen
  • Klinikum der Stadt Ludwigshafen
  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
  • Universitätsklinikum Mannheim
  • Gdanski Uniwersytet Medyczny
  • Specjalistyczna Poradnia Kardiologiczna
  • Mc Tronik
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie
  • II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)
  • Medical University of Warsaw
  • Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wearable defibrillator

Conventional treatment

Arm Description

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

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All Cause Mortality
All deaths, due to any cause
Compliance With Wearable Defibrillator Use
daily wear time of the device

Full Information

First Posted
October 3, 2011
Last Updated
December 30, 2020
Sponsor
University of California, San Francisco
Collaborators
Zoll Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01446965
Brief Title
Vest Prevention of Early Sudden Death Trial and VEST Registry
Acronym
VEST
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Zoll Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Ventricular Dysfunction, Sudden Death, Ventricular Tachycardia, Ventricular Fibrillation
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable defibrillator
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional treatment
Arm Type
No Intervention
Arm Description
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Intervention Type
Device
Intervention Name(s)
wearable defibrillator
Other Intervention Name(s)
LifeVest, wearable cardioverter-defibrillator, WCD, WD
Intervention Description
LifeVest wearable defibrillator
Primary Outcome Measure Information:
Title
Sudden Death Mortality
Description
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.
Time Frame
three months after myocardial infarction
Secondary Outcome Measure Information:
Title
All Cause Mortality
Description
All deaths, due to any cause
Time Frame
three months after myocardial infarction
Title
Compliance With Wearable Defibrillator Use
Description
daily wear time of the device
Time Frame
three months after myocardial infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey E Olgin, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byron K Lee, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark J Pletcher, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Heart Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Cardiovascular Consultants Heart Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Salinas Valley Memorial Healthcare System
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Watson Clinic for Research, Inc.
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Melbourne Cardiac Resarch Institute
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Florida Heart Group/Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Advocate Christ Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Lutheran General
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
The Heart Group/Deaconess Hospital
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Medical Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Western Kentucky Heart and Lung
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
University of Kentucky Gill Heart Institute
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Presbyterian Heart Group
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Albany Associates in Cardiology
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
United Health Services
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Long Island Jewish Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
St. Luke's- Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Huntington Hospital
City
New York
State/Province
New York
ZIP/Postal Code
11743
Country
United States
Facility Name
University Cardiovascular Associates (Rochester)
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of North Carolina @ Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Heart Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University Hospital Case Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
North Ohio Heart Center-North Ohio Research
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Cardiovascular Research Center, LLC/Mercy St Vincent
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Oklahoma Heart Institute-Hillcrest
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oregon Heart & Vascular
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Chambersburg Hospital
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Geisinger Heart Institute
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
The Guthrie Clinic/Guthrie Medical Group
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Brown Medical School-Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Providence/South Carolina Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
McLeod Health/Pee Dee Cardiology
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
Wellmont Holston Valley
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Cardiac Study Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Med. Uniklinik Heidelberg
City
Heidelberg
State/Province
Deutschland
ZIP/Postal Code
69120
Country
Germany
Facility Name
Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47169
Country
Germany
Facility Name
Klinikum Links der Weser gGmbh Klinik
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
Klinikum Göttingen Georg-August-Universität Göttingen
City
Göttingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Gdanski Uniwersytet Medyczny
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Specjalistyczna Poradnia Kardiologiczna
City
Kielce
ZIP/Postal Code
25525
Country
Poland
Facility Name
Mc Tronik
City
Lodz
ZIP/Postal Code
90-553
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie
City
Rzeszow
ZIP/Postal Code
35111
Country
Poland
Facility Name
II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02097
Country
Poland
Facility Name
Institute of Cardiology
City
Warszawa
ZIP/Postal Code
04627
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30280654
Citation
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.
Results Reference
result
Links:
URL
https://clinicaltrials.gov/show/NCT00628966
Description
Linked to VEST/PREDICTS registration: NCT00628966

Learn more about this trial

Vest Prevention of Early Sudden Death Trial and VEST Registry

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