NCT00562757

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
4 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 22, 2007

Status Verified

November 1, 2007

First QC Date

November 20, 2007

Last Update Submit

November 20, 2007

Conditions

Sudden Cardiac Death

Keywords

Wedensky modulationRisk stratificationElectrophysiologyNoninvasiveIschemic heart diseaseICD guidelinesMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review)

    Up to two years

Study Arms (1)

A

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Post myocardial infarction patients receiving ICD therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Arizona Arrhythmia Consultants

Phoenix, Arizona, 85251, United States

Location

Galichia Heart Hospital

Wichita, Kansas, 67220, United States

Location

Caritas St. Elizabeth's Hospital

Boston, Massachusetts, 02135, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

University of Bonn

Bonn, D-53105, Germany

Location

University of Mannheim

Mannheim, 68167, Germany

Location

Rikshospital

Oslo, 0027, Norway

Location

Kantonsspital Luzern

Lucerne, CH-6000, Switzerland

Location

MeSH Terms

Conditions

Death, Sudden, CardiacMyocardial IschemiaMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Harold Hoium, MBA

    Harbinger Medical, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 22, 2007

Study Start

September 1, 2003

Study Completion

October 1, 2009

Last Updated

November 22, 2007

Record last verified: 2007-11

Locations

DE(2)CH(1)US(4)NO(1)