Overview

This trial is active, not recruiting.

Condition sudden cardiac death
Sponsor Harbinger Medical, Inc.
Start date September 2003
End date October 2009
Trial size 320 participants
Trial identifier NCT00562757, HMI-HIP

Summary

The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups

Primary Outcomes

Measure
Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review)
time frame: Up to two years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Post myocardial infarction patients receiving ICD therapy Exclusion Criteria: - Patients unable to give consent - Pacemaker dependant patients - Pregnant women

Additional Information

Official title The Harbinger ICD Patient (HIP) Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by Harbinger Medical, Inc..