Vest Prevention of Early Sudden Death Trial and VEST Registry

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Sudden Death Mortality	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.

Secondary Outcome Measures

Name	Time	Method
Compliance With Wearable Defibrillator Use	three months after myocardial infarction	daily wear time of the device
All Cause Mortality	three months after myocardial infarction	All deaths, due to any cause

Locations (71): Alaska Heart Institute
🇺🇸
Anchorage, Alaska, United States
Cardiovascular Consultants Heart Center
🇺🇸
Fresno, California, United States
Salinas Valley Memorial Healthcare System
🇺🇸
Salinas, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
University of Colorado
🇺🇸
Aurora, Colorado, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
Watson Clinic for Research, Inc.
🇺🇸
Lakeland, Florida, United States
Melbourne Cardiac Resarch Institute
🇺🇸
Melbourne, Florida, United States
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Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States