Status:
COMPLETED
Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Congestive Heart Failure
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
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 appropria...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00916435
Start Date
March 1 2005
End Date
December 1 2011
Last Update
April 21 2015
Active Locations (2)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110