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Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00916435
Acronym
ICD-EGMs
Enrollment
630
Registered
2009-06-09
Start date
2005-03-31
Completion date
2011-12-31
Last updated
2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cardiomyopathies, Congestive Heart Failure, Sudden Cardiac Death

Keywords

Arrhythmia, Cardiac Arrest, Cardiomyopathy, Heart Failure

Brief summary

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)from enrollment up to 72 months

Secondary

MeasureTime frame
Composite heart failure outcome (HF hospitalization, HF death, heart transplant)from enrollment up to 72 months
All-cause mortalityfrom enrollment up to 72 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026