Global Electrical Heterogeneity and Clinical Outcomes

Completed

• Conditions: Heart Failure; Implantable Defibrillator User; Ventricular Arrythmia

• Registration Number: NCT03210883
• Lead Sponsor: Larisa Tereshchenko

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Status Verified: 2021-07
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-05
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3471

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
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)
sustained monomorphic ventricular tachycardia	up to 15 years	Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)

Trial Locations

Locations (6)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Veteran Administration Portland Healthcare System; 🇺🇸 Portland, Oregon, United States

Stanford University; 🇺🇸 Stanford, California, United States