Sudden Cardiac Death Clinical Trial
Official title:
The Harbinger ICD Patient (HIP) Study
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
Sudden cardiac death (SCD) accounts for half of all deaths from cardiovascular causes, with
an annual incidence of 1 to 2 deaths per 1000 population. In the United States this
translates to between 300,000 to more than 400,000 deaths annually. Results from numerous
large, well designed clinical trials have demonstrated the efficacy of the implantable
cardioverter-defibrillator (ICD) for improving survival in patients with ischemic heart
disease. However, measures used to risk stratify patients, such as left ventricular ejection
fraction do not adequately identify those patients who can most benefit from ICD therapy. As
a result, many patients who currently receive an ICD do not use the device. In addition,
many more patients who could benefit from ICD therapy are outside of current guidelines and
do not have access to this life-saving therapy.
This prospective study was intended to determine how well the Harbinger Wedensky Modulation
Index (WMI) technique risk stratifies patients into two groups: those needing antiarrhythmic
therapy and those who do not need antiarrhythmic therapy.
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Observational Model: Case Control, Time Perspective: Prospective
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