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Global Electrical Heterogeneity and Clinical Outcomes

Global Electrical Heterogeneity and Clinical Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03210883
Acronym
GEHCO
Enrollment
3471
Registered
2017-07-07
Start date
2017-07-01
Completion date
2021-07-05
Last updated
2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Implantable Defibrillator User, Ventricular Arrythmia

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.

Interventions

None listed

Sponsors

American Heart Association
CollaboratorOTHER
Larisa Tereshchenko
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)up to 15 yearsSustained 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 therapyup to 15 yearsAll-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy

Secondary

MeasureTime frameDescription
sustained monomorphic ventricular tachycardiaup to 15 yearsSustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
sustained polymorphic ventricular tachycardia / ventricular fibrillationup to 15 yearssustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026