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NCT00562757 Clinical Trial

Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias

Sudden Cardiac Death Clinical Trial

— HIP  

Official title:
The Harbinger ICD Patient (HIP) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00562757
Other study ID # HMI-HIP
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 20, 2007
Last updated November 20, 2007
Start date September 2003
Est. completion date October 2009

Study information
Verified date November 2007
Source Harbinger Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardGermany: Ethics CommissionNorway:National Committee for Medical and Health Research EthicsSwitzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 320
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

- Patients unable to give consent

- Pacemaker dependant patients

- Pregnant women

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University of Bonn Bonn
Germany University of Mannheim Mannheim
Norway Rikshospital Oslo
Switzerland Kantonsspital Luzern Luzern
United States Caritas St. Elizabeth's Hospital Boston Massachusetts
United States Arizona Arrhythmia Consultants Phoenix Arizona
United States Mayo Clinic Rochester Minnesota
United States Galichia Heart Hospital Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Harbinger Medical, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Norway,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) Up to two years
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