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Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias

The Harbinger ICD Patient (HIP) Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00562757
Acronym
HIP
Enrollment
320
Registered
2007-11-22
Start date
2003-09-30
Completion date
2009-10-31
Last updated
2007-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Cardiac Death

Keywords

Wedensky modulation, Risk stratification, Electrophysiology, Noninvasive, Ischemic heart disease, ICD guidelines, Myocardial infarction

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.

Interventions

None listed

Sponsors

Harbinger Medical, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Post myocardial infarction patients receiving ICD therapy

Exclusion criteria

* Patients unable to give consent * Pacemaker dependant patients * Pregnant women

Design outcomes

Primary

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

Countries

Germany, Norway, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026