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Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias (HIP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Harbinger Medical, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562757
First Posted: November 22, 2007
Last Update Posted: November 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Harbinger Medical, Inc.
  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

Further study details as provided by Harbinger Medical, Inc.:

Primary Outcome Measures:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

  • Patients unable to give consent
  • Pacemaker dependant patients
  • Pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562757


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
Sponsors and Collaborators
Harbinger Medical, Inc.
Investigators
Study Director: Harold Hoium, MBA Harbinger Medical, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00562757     History of Changes
Other Study ID Numbers: HMI-HIP
First Submitted: November 20, 2007
First Posted: November 22, 2007
Last Update Posted: November 22, 2007
Last Verified: November 2007

Keywords provided by Harbinger Medical, Inc.:
Wedensky modulation
Risk stratification
Electrophysiology
Noninvasive
Ischemic heart disease
ICD guidelines
Myocardial infarction

Additional relevant MeSH terms:
Death
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden