GEHCO: Global Electrical Heterogeneity and Clinical Outcomes
Study Details
Study Description
Brief Summary
This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock) [up to 15 years]
Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)
- Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy [up to 15 years]
All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy
Secondary Outcome Measures
- sustained monomorphic ventricular tachycardia [up to 15 years]
Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
- sustained polymorphic ventricular tachycardia / ventricular fibrillation [up to 15 years]
sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
Eligibility Criteria
Criteria
Inclusion Criteria:
- records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Exclusion Criteria:
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absent baseline pre-implant digital ECG;
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missing data on clinical predictors and covariates;
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missing ICD programming data (including number of intervals to detect [NID] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing [ATP] programming);
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missing outcomes data.
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records of patients with inherited channelopathies (e.g. long QT syndrome, Brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
2 | Stanford University | Stanford | California | United States | 94305 |
3 | University of Colorado | Aurora | Colorado | United States | 80045 |
4 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
5 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
6 | Veteran Administration Portland Healthcare System | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Larisa Tereshchenko
- American Heart Association
Investigators
- Principal Investigator: Larisa G Tereshchenko, MD, PhD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
- STUDY00016754