Developing Methods for Reconstructing Electrical Heart Activity

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03947021
• Other study ID #: METC 11-2-043
• Secondary ID: NHS 2007T51
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Conduction Defect
• Heart Diseases

Intervention

Radiation:
• Computed tomography (CT) scan
A CT scan of thorax and heart will be performed in the CT+BSPM group.

Device:
• Body-surface potential mapping
Measurement of 256-lead body-surface electrocardiogram

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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