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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Maastricht, Netherlands
- Maastricht University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: BSPM-only group
Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).
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Measurement of 256-lead body-surface electrocardiogram
|
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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.
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Measurement of 256-lead body-surface electrocardiogram
A CT scan of thorax and heart will be performed in the CT+BSPM group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Epicardial potentials
Time Frame: Day one, direct measurement
|
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
|
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Epicardial electrograms
Time Frame: Day one, direct measurement
|
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
Time Frame: Day one, direct measurement
|
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
Time Frame: Day one, direct measurement
|
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 (%).
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Day one, direct measurement
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 11-2-043
- NHS 2007T51 (Other Grant/Funding Number: Netherlands Heart Foundation)
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