Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation. — VIGILANCE  

Cardiovascular Diseases Clinical Trial

Official title: Noninvasive Electrocardiographic Imaging for Individuals at Risk for Apparently Idiopathic Ventricular Fibrillation.

Status Enrolling by invitation

Clinical Trial Summary

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with unexplained polymorphic ventricular tachycardia (VT) and/or ventricular fibrillation (VF), in patients with specific genetic mutations regarding sudden cardiac death or sudden cardiac arrest, in their family members and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI).

Also a National Dutch registry for patients with unexplained polymorphic VT and/or VF and their family members will be created.

By combining the data from the registry and the results of ECGI, The investigators hope to identity risk markers for patients at higher risk for apparently idiopathic ventricular fibrillation, and use these for an adapted flow chart for the 'general'population of patients at risk for unexplained polymorphic VT and/or VF. The investigators aim to be able to identify patients before the first arrhythmic event, and aim for better treatment strategies in the future.

Clinical Trial 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 polymorphic VT or idiopathic VF 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 VIGILANCE study:

1. ECGI will be used to noninvasively characterize the epicardial electrophysiological substrate and triggers of:

• Patients with unexplained polymorphic VT and VF,

• Index patients of family cohorts with a specific genetic mutation related to arrhythmogenesis, at high risk for unexplained polymorphic VT and/or VF.

• Family members,

• A control cohort. Results will be evaluated for risk stratification.

2. All unexplained polymorphic VT and/or VF patients and their family members will be asked to participate in a National Dutch registry, and these date will be analysed to determine their prognostic value in terms of arrhythmia risk ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrest
• Cardiac Arrhythmia
• Cardiovascular Diseases
• Death
• Death, Sudden, Cardiac
• Genetic Disease
• Genetic Diseases, Inborn
• Heart Arrest
• Idiopathic Ventricular Fibrillation
• Polymorphic Ventricular Tachycardia
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Fibrillation

• NCT number: NCT03963271
• Study type: Observational [Patient Registry]
• Source: Maastricht University Medical Center
• Status: Enrolling by invitation
• Start date: April 10, 2019
• Completion date: April 10, 2023