Clinical trial NCT00562757: Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias
Official title: The Harbinger ICD Patient (HIP) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Cardiac Death
Keywords: Wedensky modulation
Risk stratification
Electrophysiology
Noninvasive
Ischemic heart disease
ICD guidelines
Myocardial infarction
Lead sponsor: Harbinger Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

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

Primary outcomes:
measure: Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review)
timeFrame: Up to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Wichita
country: United States
facility: Galichia Heart Hospital
state: Kansas
city: Boston
country: United States
facility: Caritas St. Elizabeth's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bonn
country: Germany
facility: University of Bonn
city: Mannheim
country: Germany
facility: University of Mannheim
city: Oslo
country: Norway
facility: Rikshospital
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Harbinger Medical, Inc.
name: Harold Hoium, MBA
role: STUDY_DIRECTOR
References: