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Clinical Trials/NCT03947021
NCT03947021
Unknown
Not Applicable

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

Maastricht University Medical Center1 site in 1 country65 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
Maastricht University Medical Center
Enrollment
65
Locations
1
Primary Endpoint
Epicardial potentials
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
March 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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).

Secondary Outcomes

  • Disease-specific differences in primary outcome measures(Day one, direct measurement)

Study Sites (1)

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