Developing Methods for Reconstructing Electrical Heart Activity

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Diseases, Cardiac Conduction Defect

Intervention / Treatment
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* Radiation: Computed tomography (CT) scan
* Device: Body-surface potential mapping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BSPM-only group<br>Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes). | Device: Body-surface potential mapping<br>* Measurement of 256-lead body-surface electrocardiogram<br>|
| Experimental: CT+BSPM group<br>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. | Radiation: Computed tomography (CT) scan<br>* A CT scan of thorax and heart will be performed in the CT+BSPM group.<br>Device: Body-surface potential mapping<br>* Measurement of 256-lead body-surface electrocardiogram<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrocardiography, Body Surface Potential Mapping, Computational Biology