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

Johns Hopkins University

Status: Completed

Conditions: Arrhythmia; Cardiomyopathies; Sudden Cardiac Death; Congestive Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT00916435

1K99HL094665-01 (in review)

Details and patient eligibility

About

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.

Enrollment: 630 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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