Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms

Johns Hopkins University630 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

630

Conditions

Congestive Heart Failure Sudden Cardiac Death Arrhythmia Cardiomyopathies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

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

Data from ClinicalTrials.gov

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