Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms
Completed
- Conditions
- Congestive Heart FailureSudden Cardiac DeathCardiomyopathiesArrhythmia
- Registration Number
- NCT00916435
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP) from enrollment up to 72 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States