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

November 20, 2007 updated by: Harbinger Medical, Inc.

The Harbinger ICD Patient (HIP) Study

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, D-53105
        • University of Bonn
      • Mannheim, Germany, 68167
        • University of Mannheim
  • Norway
      • Oslo, Norway, 0027
        • Rikshospital
  • Switzerland
      • Luzern, Switzerland, CH-6000
        • Kantonsspital Luzern
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85251
        • Arizona Arrhythmia Consultants
    • Kansas
      • Wichita, Kansas, United States, 67220
        • Galichia Heart Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St. Elizabeth's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A
Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbinger Medical, Inc.

Investigators

  • Study Director: Harold Hoium, MBA, Harbinger Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

November 22, 2007

Last Update Submitted That Met QC Criteria

November 20, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMI-HIP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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