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OpenTrials
Completed

NCT Number: NCT03210883

Global Electrical Heterogeneity and Clinical Outcomes

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Implantable Defibrillator User Ventricular Arrythmia

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: up to 15 years

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

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

    Time frame: up to 15 years

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

Secondary outcomes

  1. sustained monomorphic ventricular tachycardia

    Time frame: up to 15 years

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

  2. sustained polymorphic ventricular tachycardia / ventricular fibrillation

    Time frame: up to 15 years

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

Sponsors and collaborators

Lead sponsor

Larisa Tereshchenko

Other

Collaborators

  • American Heart Association

Registry information

Acronym: GEHCO

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2017
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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