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| ID | Type | Description | Link |
|---|---|---|---|
| NHS 2007T51 | Other Grant/Funding Number | Netherlands Heart Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BSPM-only group | Experimental | Participants will only receive body-surface potential mapping (BSPM) with an extensive electrode set (256 electrodes). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed tomography (CT) scan | Radiation | A CT scan of thorax and heart will be performed in the CT+BSPM group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%). |
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Overall Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Netherlands |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D000075224 | Cardiac Conduction System Disease |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018780 | Body Surface Potential Mapping |
| ID | Term |
|---|---|
| D014672 | Vectorcardiography |
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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| Body-surface potential mapping | Device | Measurement of 256-lead body-surface electrocardiogram |
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| Day one, direct measurement |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |