Torso surface electrical mapping as a diagnostic aid in cardiac resynchronisation therapy and ventricular tachycardia

Among patients with arrhythmia in which the mechanism or sequence of electrical activation is not readily diagnosed by standard 12-lead electrocardiogram (ECG), is Torso Surface Electrical Mapping more useful than ECG in arrhythmia mechanism and guiding treatment strategy.

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000526774

Enrollment

Registered

2013-05-13

Start date

2013-07-01

Completion date

2017-06-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study hypotheses are (1) that Torso Surface Electrical Mapping (TSEM) provides a more complete definition of the electrical activation of the heart compared to the standard electrocardiogram (ECG) in patients with arrhythmia, and (2) that this more complete definition is useful in guiding arrhythmia treatment strategies, in particular radiofrequency ablation. The project aims to test TSEM in patients in whom the mechanism &/or sequence of arrhythmia is not easily diagnosed by ECG alone. These patients are a minority of all patients with arrhythmia, and include those with recurrent ventricular tachycardia, atypical atrial flutter, atrial tachycardia, atrial fibrillation (undergoing ablation) and ventricular dyssynchrony.

Interventions

Patients scheduled for invasive electrophysiological study will undergo Torso Surface Electrical Mapping (TSEM). TSEM involves the recording of electrical potential from approximately 128 electrodes over the body surface. These recordings are then combined with 3D geometry of the chest wall and heart gained from computed tomography (CT) imaging, in order to project electrical activation back to the heart surface with use of a mathematical model. Participants undergo a single TSEM recording whilst in their clinical arrhythmia, either prior to, or during invasive electrophysiological study. TSEM is anticipated to take approximately 20 minutes including time taken to place electrodes over the torso. CT imaging will be obtained prior to TSEM recording, as part of the routine clinical work-up of the patient to facilitate invasive electrophysiological study.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to 100 Years

Healthy volunteers

Inclusion criteria

Patients undergoing electrophysiological study for arrhythmia, the mechanism of which is not easily diagnosed by 12-lead ECG. Participants must have a clinical requirement for CT scan of the chest.

Exclusion criteria

Exclusion criteria of the study are: age <15yrs, inability to provide informed consent, pregnancy, limited mobility or inability to lie flat for 20 minutes, previous severe skin reaction to ECG electrodes, fragile skin likely to result in skin tear, and an eGFR of less than or equal to 30ml/min

Outcome results