Developing Methods for Reconstructing Electrical Heart Activity

Developing Mathematical Methods for Non-invasive Reconstruction of Electrical Heart Activity From Body-surface Electrocardiograms and a CT-based Torso-heart Geometry

Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Cardiac Conduction Defect
• Intervention / Treatment: Device: Body-surface potential mapping; Radiation: Computed tomography (CT) scan

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Overall Inclusion Criteria:

• 18 years or older
• able to provide informed consent
• Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC), demonstrated ventricular arrhythmias (resuscitation, (non)sustained ventricular tachycardia, ventricular fibrillation)
• Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator

Additional Inclusion Criteria for group 1 (CT group):

- Existing medical indication for a cardiac CT scan unrelated to this research

There are no additional inclusion criteria for group 2 (no-CT group).

Exclusion Criteria:

- Known strong reaction against electrode attachment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BSPM-only group; Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).	Device: Body-surface potential mapping; Measurement of 256-lead body-surface electrocardiogram
Experimental: CT+BSPM group; Participants will receive body-surface potential measurements (BSPM) and a CT scan. These data will allow for non-invasive reconstruction of electrical potentials at the heart surface.	Device: Body-surface potential mapping; Measurement of 256-lead body-surface electrocardiogram; Radiation: Computed tomography (CT) scan; A CT scan of thorax and heart will be performed in the CT+BSPM group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epicardial potentials	Primary outcome data include reconstructed electrical heart activity such as: - epicardial potentials (units: millivolts [mV]) These outcome data are obtained at the moment of inclusion. The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records: - Reconstructed epicardial potentials (mV) will be compared to selected invasive epicardial potentials (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data	Day one, direct measurement
Epicardial electrograms	Primary outcome data include reconstructed electrical heart activity such as: - epicardial electrograms (units: millivolts [mV] over milliseconds [ms]) These outcome data are obtained at the moment of inclusion. The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records: - Reconstructed electrograms (mV) will be compared to selected invasive epicardial electrograms (mV) obtained from catheter-based recordings or pacemaker-based recordings available as clinical data	Day one, direct measurement
Epicardial activation and recovery sequences	Primary outcome data include reconstructed electrical heart activity such as: - epicardial activation and recovery isochrones (units: milliseconds [ms]) These outcome data are obtained at the moment of inclusion. The primary outcome measures are a comparison of the primary outcome data with invasive outcome data available from clinical records: - Reconstructed activation and recovery sequences (ms) will be compared to recorded catheter-based sequences from clinical data (ms).	Day one, direct measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific differences in primary outcome measures	The secondary study endpoints include disease-specific differences of the primary outcome measures, which may include abnormal (low-amplitude, fractionated) electrograms and abnormal activation and recovery sequences. Depending on the primary measure, these differences will be expressed in absolute units (mV, ms) or relative differences (%).	Day one, direct measurement

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Electrocardiography; Body Surface Potential Mapping; Computational Biology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiac Conduction System Disease
• Other Study ID Numbers: METC 11-2-043; NHS 2007T51 (Other Grant/Funding Number: Netherlands Heart Foundation)