Developing Methods for Reconstructing Electrical Heart Activity

NCT03947021 | Unknown

• 2 other identifiers: METC 11-2-043NHS 2007T51
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases; Cardiac Conduction Defect

Keywords

Electrocardiography; Body Surface Potential Mapping; Computational Biology

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Disease-specific differences in primary outcome measures

  Day one, direct measurement

Study Arms (2)

BSPM-only group

EXPERIMENTAL

Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).

Device: Body-surface potential mapping

CT+BSPM group

EXPERIMENTAL

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; Device: Body-surface potential mapping

Interventions

Computed tomography (CT) scan RADIATION

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

CT+BSPM group

Body-surface potential mapping DEVICE

Measurement of 256-lead body-surface electrocardiogram

BSPM-only group; CT+BSPM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Known strong reaction against electrode attachment

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Heart Diseases; Cardiac Conduction System Disease

Interventions

Body Surface Potential Mapping

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vectorcardiography; Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: May 13, 2019
• Study Start: January 1, 2012
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

NL (1)