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

NCT04548804 | Enrolling By Invitation DMC

• 3 other identifiers: METC19-065NL69831.068.19300260
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular 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

Outcome Measures

Primary Outcomes (2)

• ECG-Imaging outcome: epicardial potentials

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

  3 years

• ECG-Imaging outcome: activation and repolarization maps

  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.

  3 years

Secondary Outcomes (2)

• (Possible) Prognostic risk factors for recurrent ventricular arrhythmias

  6 years

• Recurrence of ventricular arrhythmias

  6 years

Study Arms (2)

Control

EXPERIMENTAL

Control subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR scan

Diagnostic Test: ECG-Imaging

Diseased

EXPERIMENTAL

Diseased subjects receiving body-surface potential mapping (BSPM) and either a CT-scan or a CMR scan. Outcome measures from these procedures will be compared to controls.

Diagnostic Test: ECG-Imaging

Interventions

ECG-Imaging DIAGNOSTIC_TEST

A body surface potential mapping and a cardiac + low dose CT-scan

Control; Diseased

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 14.
• Being unable to give informed consent.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Jessa Hospital: collaborator

Study Sites (2)

Jessa Hospital

Hasselt, Limburg, 3500, Netherlands

Location

Maastricht University Medical Center

Maastricht, Limburg, 6229hx, Netherlands

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Death, Sudden, Cardiac; Heart Arrest; Death; Arrhythmias, Cardiac; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The treating physician is not informed about the results of the procedure.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both groups (control and diseased) will undergo a body surface potential mapping and a cardiac + low dose CT-scan.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: June 10, 2020
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

NL (2)