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Trial registered on ANZCTR


Registration number
ACTRN12613000526774
Ethics application status
Not yet submitted
Date submitted
9/05/2013
Date registered
13/05/2013
Date last updated
13/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Torso surface electrical mapping as a diagnostic aid in cardiac resynchronisation therapy and ventricular tachycardia
Scientific title
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.
Secondary ID [1] 280773 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrhythmia 286829 0
Condition category
Condition code
Cardiovascular 287140 287140 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287125 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator is a standard 12-lead electrocardiogram (ECG), taken during the same clinical arrhythmia episode as TSEM. The standard ECG takes approximately 5 minutes to acquire.
Control group
Active

Outcomes
Primary outcome [1] 289545 0
Diagnosis of mechanism and/or sequence of activation during arrhythmia, as adjudicated by two independent Electrophysiologists.
Timepoint [1] 289545 0
At time of invasive electrophysiological study, which is performed during the same clinical arrhythmia episode as TSEM.
Secondary outcome [1] 302706 0
nil
Timepoint [1] 302706 0
nil

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting with complex arrhythmia will be enrolled prior to invasive electrophysiological study. All patients will undergo both TSEM and standard ECG. There is no blinding (this is a small scoping study)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The information gained by TSEM and standard ECG will be compared to data gathered at invasive electrophysiological study
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis is a qualitative assessment of the utility of TSEM compared to 12-lead ECG

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5072 0
New Zealand
State/province [1] 5072 0

Funding & Sponsors
Funding source category [1] 287255 0
University
Name [1] 287255 0
Bioengineering Institute, University of Auckland
Country [1] 287255 0
New Zealand
Primary sponsor type
University
Name
Bioengineering Institute, University of Auckland
Address
Level 6, Symonds St, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 286009 0
None
Name [1] 286009 0
Address [1] 286009 0
Country [1] 286009 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289235 0
Health and Disability Ethics Committee
Ethics committee address [1] 289235 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289235 0
New Zealand
Date submitted for ethics approval [1] 289235 0
24/05/2013
Approval date [1] 289235 0
Ethics approval number [1] 289235 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34389 0
Dr Darren Hooks
Address 34389 0
Cardiology Department
Christchurch Hospital
6 Riccarton Ave
Christchurch 8011
Country 34389 0
New Zealand
Phone 34389 0
+64211801114
Fax 34389 0
Email 34389 0
[email protected]
Contact person for public queries
Name 17636 0
Darren Hooks
Address 17636 0
Cardiology Department
Christchurch Hospital
6 Riccarton Ave
Christchurch 8011
Country 17636 0
New Zealand
Phone 17636 0
+64211801114
Fax 17636 0
Email 17636 0
[email protected]
Contact person for scientific queries
Name 8564 0
Darren Hooks
Address 8564 0
Cardiology Department
Christchurch Hospital
6 Riccarton Ave
Christchurch 8011
Country 8564 0
New Zealand
Phone 8564 0
+64211801114
Fax 8564 0
Email 8564 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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