Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST)
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ClinicalTrials.gov Identifier: NCT01446965 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 5, 2011
Last Update Posted
: November 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Ventricular Dysfunction Sudden Death Ventricular Tachycardia Ventricular Fibrillation | Device: wearable defibrillator | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator |
Study Start Date : | July 2008 |
Estimated Primary Completion Date : | May 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Wearable defibrillator
subjects will use a wearable defibrillator for three months following myocardial infarction
|
Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
|
No Intervention: Conventional treatment |
- Sudden death mortality [ Time Frame: three months after myocardial infarction ]
- Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ]
- incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ]
- adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
- compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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)
-
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 |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01446965 History of Changes |
Other Study ID Numbers: |
90D0114 |
First Posted: | October 5, 2011 Key Record Dates |
Last Update Posted: | November 9, 2017 |
Last Verified: | November 2017 |
Keywords provided by University of California, San Francisco:
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 |
Additional relevant MeSH terms:
Infarction Myocardial Infarction Death Tachycardia Ventricular Dysfunction Tachycardia, Ventricular Ventricular Fibrillation Death, Sudden |
Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arrhythmias, Cardiac |