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Sponsored by: |
Harbinger Medical, Inc. |
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Information provided by: | Harbinger Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00562757 |
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
Condition |
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Sudden Cardiac Death |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | The Harbinger ICD Patient (HIP) Study |
Enrollment: | 320 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | October 2009 |
Groups/Cohorts |
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A
Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Post myocardial infarction patients who received an ICD are included. Enrollment is at eight sites - four in the USA and four in three European countries. The enrollment sites are hospitals and teaching institutions.
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Arizona Arrhythmia Consultants | |
Phoenix, Arizona, United States, 85251 | |
United States, Kansas | |
Galichia Heart Hospital | |
Wichita, Kansas, United States, 67220 | |
United States, Massachusetts | |
Caritas St. Elizabeth's Hospital | |
Boston, Massachusetts, United States, 02135 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55902 | |
Germany | |
University of Bonn | |
Bonn, Germany, D-53105 | |
University of Mannheim | |
Mannheim, Germany, 68167 | |
Norway | |
Rikshospital | |
Oslo, Norway, 0027 | |
Switzerland | |
Kantonsspital Luzern | |
Luzern, Switzerland, CH-6000 |
Study Director: | Harold Hoium, MBA | Harbinger Medical, Inc. |
Study ID Numbers: | HMI-HIP |
Study First Received: | November 20, 2007 |
Last Updated: | November 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00562757 History of Changes |
Health Authority: | United States: Institutional Review Board; Germany: Ethics Commission; Norway: The National Committees for Research Ethics in Norway; Switzerland: Ethikkommission |
Wedensky modulation Risk stratification Electrophysiology Noninvasive |
Ischemic heart disease ICD guidelines Myocardial infarction |
Death Heart Diseases Myocardial Ischemia Death, Sudden Heart Arrest |
Ischemia Death, Sudden, Cardiac Infarction Myocardial Infarction Arrhythmias, Cardiac |
Death Pathologic Processes Heart Diseases Death, Sudden |
Cardiovascular Diseases Heart Arrest Death, Sudden, Cardiac |