Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias (HIP)
Recruitment status was Active, not recruiting
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Purpose
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.
| Condition |
|---|
|
Sudden Cardiac Death |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | The Harbinger ICD Patient (HIP) Study |
- Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) [ Time Frame: Up to two years ]
| Enrollment: | 320 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | October 2009 |
| Groups/Cohorts |
|---|
|
A
Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups
|
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.
Eligibility| 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:
- Post myocardial infarction patients receiving ICD therapy
Exclusion Criteria:
- Patients unable to give consent
- Pacemaker dependant patients
- Pregnant women
Contacts and Locations| 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. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00562757 History of Changes |
| Other Study ID Numbers: | HMI-HIP |
| Study First Received: | November 20, 2007 |
| Last Updated: | November 20, 2007 |
| Health Authority: | United States: Institutional Review Board Germany: Ethics Commission Norway:National Committee for Medical and Health Research Ethics Switzerland: Ethikkommission |
Keywords provided by Harbinger Medical, Inc.:
|
Wedensky modulation Risk stratification Electrophysiology Noninvasive |
Ischemic heart disease ICD guidelines Myocardial infarction |
Additional relevant MeSH terms:
|
Death, Sudden, Cardiac Death Heart Arrest Heart Diseases |
Cardiovascular Diseases Death, Sudden Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013