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

Johns Hopkins University2 sites in 1 country630 target enrollmentMarch 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congestive Heart Failure
Sponsor: Johns Hopkins University
Enrollment: 630
Locations: 2
Primary Endpoint: sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
Status: Completed
Last Updated: 11 years ago

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.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

December 2011

Last Updated

11 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Principal Investigator

Larisa Tereshchenko

Instructor of Medicine

Johns Hopkins University

•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

•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

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

Time Frame: from enrollment up to 72 months

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