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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00916435

Collaborator

Washington University School of Medicine (Other)

630

Enrollment

Locations

Duration (Months)

315

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure Sudden Cardiac Death Arrhythmia Cardiomyopathies

Study Design

Study Type:

Observational

Actual Enrollment :

630 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21205
2	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Johns Hopkins University
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