CompletedNot Applicable

Global Electrical Heterogeneity and Clinical Outcomes

United States3,471 participantsStarted 2017-07-01

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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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.

What they're measuring

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

Timeframe: up to 15 years

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

Timeframe: up to 15 years

Trial details

NCT IDNCT03210883

SponsorLarisa Tereshchenko

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-05