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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,348
LifeVest wearable defibrillator
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.
Time frame: three months after myocardial infarction
All Cause Mortality
All deaths, due to any cause
Time frame: three months after myocardial infarction
Compliance With Wearable Defibrillator Use
daily wear time of the device
Time frame: three months after myocardial infarction
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Christiana Care Health Services
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...and 61 more locations