Global Electrical Heterogeneity and Clinical Outcomes

Larisa Tereshchenko3,471 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,471

Conditions

Heart Failure Implantable Defibrillator User Ventricular Arrythmia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications Exclusion Criteria: * absent baseline pre-implant digital ECG; * missing data on clinical predictors and covariates; * 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); * missing outcomes data. * 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.

Locations (6)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Stanford University

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)

Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)

Time frame: up to 15 years

Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy

All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy

Time frame: up to 15 years

Secondary Outcomes

sustained monomorphic ventricular tachycardia

Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)

Time frame: up to 15 years

sustained polymorphic ventricular tachycardia / ventricular fibrillation

sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)

Time frame: up to 15 years

Data from ClinicalTrials.gov

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