Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias
- Conditions
- Sudden Cardiac Death
- Registration Number
- NCT00562757
- Lead Sponsor
- Harbinger Medical, Inc.
- Brief Summary
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
- Post myocardial infarction patients receiving ICD therapy
- Patients unable to give consent
- Pacemaker dependant patients
- Pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) Up to two years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Kantonsspital Luzern
🇨🇭Luzern, Switzerland
University of Bonn
🇩🇪Bonn, Germany
Arizona Arrhythmia Consultants
🇺🇸Phoenix, Arizona, United States
Galichia Heart Hospital
🇺🇸Wichita, Kansas, United States
Caritas St. Elizabeth's Hospital
🇺🇸Boston, Massachusetts, United States
University of Mannheim
🇩🇪Mannheim, Germany
Rikshospital
🇳🇴Oslo, Norway