Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms (ICD-EGMs)

April 19, 2015 updated by: Larisa Tereshchenko, Johns Hopkins University

Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure

The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:

  • to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
  • to predict progression of heart failure in patients with ICD.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

630

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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

Probability Sample

Study Population

Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death

Description

Inclusion Criteria:

  • history of acute MI at least 4 weeks old
  • non-ischemic LV dysfunction for at least 9 months
  • who have an EF < or = to 35%
  • who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
  • undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD

Exclusion Criteria:

  • inability or unwillingness to provide valid informed consent
  • pregnancy
  • any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
Time Frame: from enrollment up to 72 months
from enrollment up to 72 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite heart failure outcome (HF hospitalization, HF death, heart transplant)
Time Frame: from enrollment up to 72 months
from enrollment up to 72 months
All-cause mortality
Time Frame: from enrollment up to 72 months
from enrollment up to 72 months

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

Washington University School of Medicine

Investigators

  • Principal Investigator: Larisa G Tereshchenko, MD, PhD, Johns Hopkins University
  • Principal Investigator: Ronald D Berger, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 19, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K99HL094665-01 (in review)

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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