Developing Methods for Reconstructing Electrical Heart Activity

Not Applicable

• Conditions: Cardiac Conduction Defect; Heart Diseases
• Interventions: Device: Body-surface potential mapping; Radiation: Computed tomography (CT) scan

• Registration Number: NCT03947021
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BSPM-only group	Body-surface potential mapping	Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes).
CT+BSPM group	Computed tomography (CT) scan	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.
CT+BSPM group	Body-surface potential mapping	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.

Primary Outcome Measures

Name	Time	Method
Epicardial potentials	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
Epicardial electrograms	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
Epicardial activation and recovery sequences	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).

Secondary Outcome Measures

Name	Time	Method
Disease-specific differences in primary outcome measures	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 (%).

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands