Vest Prevention of Early Sudden Death Trial and VEST Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)

Conditions
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Myocardial Infarction, Ventricular Dysfunction, Sudden Death, Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Device: wearable defibrillator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable defibrillator<br>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<br>* LifeVest wearable defibrillator<br>* Other names: WD;|
| No Intervention: Conventional treatment<br>subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months after myocardial infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality | All deaths, due to any cause | three months after myocardial infarction | 
| Compliance With Wearable Defibrillator Use | daily wear time of the device | three months after myocardial infarction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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