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

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ClinicalTrials.gov Identifier: NCT01446965
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Myocardial Infarction
Ventricular Dysfunction
Sudden Death
Ventricular Tachycardia
Ventricular Fibrillation
Intervention Device: wearable defibrillator
Enrollment 2348
Recruitment Details From July 2008 through April 2017, the investigators enrolled 2348 participants at 76 sites in the United States, at 24 in Poland, at 6 in Germany, and at 2 in Hungary. One U.S. site was dismissed on June 24, 2014, and the 46 participants at that site were excluded from the analyses, due to irregularities found by the institutional review board at the site. Thus, a total of 2302 participants were included in the analyses (1524 participants in the device group and 778 in the control group).
Pre-assignment Details  
Arm/Group Title Wearable Defibrillator Conventional Treatment
Hide Arm/Group Description

subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (WCD) (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients

wearable defibrillator: LifeVest wearable defibrillator

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Period Title: Randominization
Started 1554 794
Completed 1524 778
Not Completed 30 16
Reason Not Completed
One site was dismissed due to IRB irregularity             30             16
Period Title: Participants Followed and Analyzed
Started 1524 778
Received WCD 1481 0
Never Wore WCD [1] 43 0
Never Given WCD 0 758
Given WCD Out of Protocol [2] 0 20
Completed 1514 766
Not Completed 10 12
Reason Not Completed
Lost to Follow-up             10             12
[1]
n=43 participants in the treatment group withdrew consent prior to receiving WCD or refused WCD fitting
[2]
n=20 participants in the control group received WCD by prescription outside of protocol by treating physician
Arm/Group Title Wearable Defibrillator Conventional Treatment Total
Hide Arm/Group 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

wearable defibrillator: LifeVest wearable defibrillator

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients Total of all reporting groups
Overall Number of Baseline Participants 1524 778 2302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1524 participants 778 participants 2302 participants
60.9  (12.6) 61.4  (12.4) 61.2  (12.6)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1521 participants 772 participants 2293 participants
Female
413
  27.2%
195
  25.3%
608
  26.5%
Male
1108
  72.8%
577
  74.7%
1685
  73.5%
[1]
Measure Analysis Population Description: Sex data not available for all randomized
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1524 participants 778 participants 2302 participants
American Indian or Alaska Native
25
   1.6%
12
   1.5%
37
   1.6%
Asian
23
   1.5%
14
   1.8%
37
   1.6%
Native Hawaiian or Other Pacific Islander
1
   0.1%
0
   0.0%
1
   0.0%
Black or African American
143
   9.4%
75
   9.6%
218
   9.5%
White
1279
  83.9%
636
  81.7%
1915
  83.2%
More than one race
20
   1.3%
14
   1.8%
34
   1.5%
Unknown or Not Reported
33
   2.2%
27
   3.5%
60
   2.6%
Left ventricular ejection fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total amount of blood
Number Analyzed 1524 participants 778 participants 2302 participants
28.2  (6.1) 28.2  (5.8) 28.2  (6.1)
[1]
Measure Description: Left ventricular ejection fraction is reported as percent of the total amount of blood in the left ventricle pushed out with each heartbeat. An ejection fraction of 35 percent or less was an inclusion criterion for the study.
1.Primary Outcome
Title Sudden Death Mortality
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2302 participants were included in the analyses.
Arm/Group Title Wearable Defibrillator Conventional Treatment
Hide Arm/Group 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

wearable defibrillator: LifeVest wearable defibrillator

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Overall Number of Participants Analyzed 1524 778
Measure Type: Count of Participants
Unit of Measure: Participants
25
   1.6%
19
   2.4%
2.Secondary Outcome
Title All Cause Mortality
Hide Description All deaths, due to any cause
Time Frame three months after myocardial infarction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wearable Defibrillator Conventional Treatment
Hide Arm/Group 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

wearable defibrillator: LifeVest wearable defibrillator

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Overall Number of Participants Analyzed 1524 778
Measure Type: Count of Participants
Unit of Measure: Participants
48
   3.1%
38
   4.9%
3.Secondary Outcome
Title Compliance With Wearable Defibrillator Use
Hide Description daily wear time of the device
Time Frame three months after myocardial infarction
Hide Outcome Measure Data
Hide Analysis Population Description
Conventional treatment participants did not wear defibrillator.
Arm/Group Title Wearable Defibrillator Conventional Treatment
Hide Arm/Group 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

wearable defibrillator: LifeVest wearable defibrillator

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
Overall Number of Participants Analyzed 1524 0
Median (Inter-Quartile Range)
Unit of Measure: hours per day
18
(3.8 to 22.7)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wearable Defibrillator Conventional Treatment
Hide Arm/Group 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

wearable defibrillator: LifeVest wearable defibrillator

subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
All-Cause Mortality
Wearable Defibrillator Conventional Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   48/1524 (3.15%)      38/778 (4.88%)    
Hide Serious Adverse Events
Wearable Defibrillator Conventional Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   475/1524 (31.17%)      253/778 (32.52%)    
Cardiac disorders     
CHD hospitalization, 1st event post-randomization   475/1524 (31.17%)  475 253/778 (32.52%)  253
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Wearable Defibrillator Conventional Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1421/1524 (93.24%)      714/778 (91.77%)    
Cardiac disorders     
Palpitations *  327/1524 (21.46%)  182/778 (23.39%) 
Chest pain *  265/1524 (17.39%)  151/778 (19.41%) 
Gastrointestinal disorders     
Nausea *  132/1524 (8.66%)  85/778 (10.93%) 
General disorders     
Fatigue *  510/1524 (33.46%)  274/778 (35.22%) 
Trouble sleeping *  551/1524 (36.15%)  264/778 (33.93%) 
Dizziness *  344/1524 (22.57%)  166/778 (21.34%) 
Fainting *  59/1524 (3.87%)  36/778 (4.63%) 
Headache *  259/1524 (16.99%)  136/778 (17.48%) 
Musculoskeletal and connective tissue disorders     
Back pain *  283/1524 (18.57%)  137/778 (17.61%) 
Respiratory, thoracic and mediastinal disorders     
Shortness of breath *  548/1524 (35.96%)  321/778 (41.26%) 
Skin and subcutaneous tissue disorders     
Rash in any location *  216/1524 (14.17%)  50/778 (6.43%) 
Rash on torso *  184/1524 (12.07%)  27/778 (3.47%) 
Itch in any location *  243/1524 (15.94%)  45/778 (5.78%) 
Itch on torso *  205/1524 (13.45%)  22/778 (2.83%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Olgin, MD
Organization: University of California, San Francisco
Phone: 415-476-1000
EMail: jeffrey.olgin@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01446965    
Obsolete Identifiers: NCT00628966
Other Study ID Numbers: 90D0114
First Submitted: October 3, 2011
First Posted: October 5, 2011
Results First Submitted: December 4, 2020
Results First Posted: January 20, 2021
Last Update Posted: January 20, 2021