Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms

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.

Completed

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Key information

Conditions

Congestive Heart Failure Arrhythmia Arrhythmias, Cardiac Cardiomyopathies Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)

Time frame: from enrollment up to 72 months

Secondary outcomes

Composite heart failure outcome (HF hospitalization, HF death, heart transplant)

Time frame: from enrollment up to 72 months
All-cause mortality

Time frame: from enrollment up to 72 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

Washington University School of Medicine

Registry information

Official study title

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

Acronym: ICD-EGMs

Important dates

Study start: 2005
Primary completion: 2011
Study completion: 2011
First posted: Jun 9, 2009
Registry last updated: Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed