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Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias

NCT ID: NCT00562757

Last Updated: 2007-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sudden Cardiac Death

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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A

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria

* Patients unable to give consent
* Pacemaker dependant patients
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harbinger Medical, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Harold Hoium, MBA

Role: STUDY_DIRECTOR

Harbinger Medical, Inc.

Locations

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Arizona Arrhythmia Consultants

Phoenix, Arizona, United States

Site Status

Galichia Heart Hospital

Wichita, Kansas, United States

Site Status

Caritas St. Elizabeth's Hospital

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

University of Bonn

Bonn, , Germany

Site Status

University of Mannheim

Mannheim, , Germany

Site Status

Rikshospital

Oslo, , Norway

Site Status

Kantonsspital Luzern

Lucerne, , Switzerland

Site Status

Countries

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United States Germany Norway Switzerland

Other Identifiers

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HMI-HIP

Identifier Type: -

Identifier Source: org_study_id