Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

Maastricht University Medical Center2 sites in 1 country270 target enrollmentJune 10, 2020

ConditionsVentricular Tachycardia Ventricular Arrythmia Ventricular Fibrillation Polymorphic Ventricular Tachycardia Sudden Cardiac Death Sudden Cardiac Arrest Sudden Cardiac Death Due to Cardiac Arrhythmia Heart Arrest Cardiac Death Cardiac Arrest Cardiac Arrhythmia Congenital Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventricular Tachycardia
Sponsor: Maastricht University Medical Center
Enrollment: 270
Locations: 2
Primary Endpoint: ECG-Imaging outcome: epicardial potentials
Status: Enrolling By Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered.

By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.

Detailed Description

ECGI combines electrical body-surface mapping with 256 electrodes placed on the thorax with a CT-scan obtaining the anatomy of the heart and torso, hereby able to reconstruct local electrograms, activation and recovery times. In recent research, ECGI provided numerous extra insights into normal cardiac electrophysiology, but also electrophysiological disorders and disease. The results strongly suggest that ECGI can play a pivotal role in further characterizing arrhythmia mechanisms, therefore could do so for VTAs, leading to diagnosis and treatment improvement. Moreover, ECGI seems to have the potential to detect arrhythmogenic substrate in individuals before their first event, offering the possibility to diagnose and treat patients before sudden cardiac arrest occurs. In the BREACH-ECGI study: ECGI will be used to noninvasively characterize the epicardial electrophysiological substrate and triggers of: * Patients with (increased risk of) VTAs * A control cohort. Results will be evaluated for increased mechanistic understanding and risk stratification. Moreover, clinical data of subjects will be gathered. These data will be analyzed to determine their prognostic value in terms of arrhythmia risk

Registry

clinicaltrials.gov

Start Date

June 10, 2020

End Date

February 12, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, a subject must be ≥ 18 years old, have either a history of VTAs or be at risk of VTAs and have one of the following diagnoses:
•Ischemic cardiomyopathy
•Non-ischemic cardiomyopathy
•Non-structural heart disease
•Congenital heart disease (with a limitation to CCTGA and situs inversus)
•Or: a subject must be ≥ 18 years old and have a structurally normal heart with a clinical indication for a cardiac CT.

Exclusion Criteria

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•A known strong reaction against electrode attachment or contrast agent.
•Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study.
•Pregnancy, nursing or planning to be pregnant.
•The subject has an estimated glomerular filtration rate (eGFR) of \<30mL/min/1.73m2, using the MDRD calculation
•Being unable to give informed consent.

Outcomes

Primary Outcomes

ECG-Imaging outcome: epicardial potentials

Time Frame: 3 years

reconstructed epicardial potentials, represented in mV over time(s).

ECG-Imaging outcome: activation and repolarization maps

Time Frame: 3 years

Activation and repolarization maps. Acivation and repolarization times are determined from the epicardial potentials, expressed in ms. These are shown on a CT-derived or CMR-derived heart mesh. The entire activation and repolarization of the epicardium of the heart can be visualized this way.