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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Ventricular Dysfunction Sudden Death Ventricular Tachycardia Ventricular Fibrillation | Device: wearable defibrillator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2348 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | July 2008 |
Actual Primary Completion Date : | May 31, 2019 |
Actual Study Completion Date : | May 31, 2019 |

Arm | Intervention/treatment |
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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
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Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
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No Intervention: Conventional treatment
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
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- 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.
- All Cause Mortality [ Time Frame: three months after myocardial infarction ]All deaths, due to any cause
- Compliance With Wearable Defibrillator Use [ Time Frame: three months after myocardial infarction ]daily wear time of the device

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446965

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 |
Documents provided by University of California, San Francisco:
Publications of Results:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01446965 |
Obsolete Identifiers: | NCT00628966 |
Other Study ID Numbers: |
90D0114 |
First Posted: | October 5, 2011 Key Record Dates |
Results First Posted: | January 20, 2021 |
Last Update Posted: | January 20, 2021 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Myocardial Infarction Tachycardia Tachycardia, Ventricular Ventricular Dysfunction Ventricular Fibrillation Infarction Death Death, Sudden Ischemia |
Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arrhythmias, Cardiac Cardiac Conduction System Disease |