Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03947021
Enrollment
65
Registered
2019-05-13
Start date
2012-01-31
Completion date
2022-03-31
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases, Cardiac Conduction Defect

Keywords

Electrocardiography, Body Surface Potential Mapping, Computational Biology

Brief summary

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.

Interventions

A CT scan of thorax and heart will be performed in the CT+BSPM group.

DEVICEBody-surface potential mapping

Measurement of 256-lead body-surface electrocardiogram

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Epicardial potentialsDay one, direct measurementPrimary 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
Epicardial electrogramsDay one, direct measurementPrimary 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
Epicardial activation and recovery sequencesDay one, direct measurementPrimary 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).

Secondary

MeasureTime frameDescription
Disease-specific differences in primary outcome measuresDay one, direct measurementThe 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 (%).

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026