Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000929909
Ethics application status
Approved
Date submitted
30/06/2020
Date registered
18/09/2020
Date last updated
18/09/2020
Date data sharing statement initially provided
18/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
PREDICTive value of non-invasive surface ECG mapping of ATRIAL SUBSTRATE in atrial arrythmia patients: The PREDICT ATRIAL SUBSTRATE study
Scientific title
PREDICTive value of non-invasive surface ECG mapping of ATRIAL SUBSTRATE to determine areas of unhealthy tissue in atrial arrythmia patients: The PREDICT ATRIAL SUBSTRATE study
Secondary ID [1] 301654 0
None
Universal Trial Number (UTN)
Trial acronym
PREDICT ATRIAL SUBSTRATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial arrhythmia 318079 0
Atrial cardiomyopathy 318080 0
Supraventricular tachycardia 318368 0
Atrial Fibrillation 318369 0
Condition category
Condition code
Cardiovascular 316109 316109 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A 252-electrode surface ECG mapping vest will be applied with an electro-anatomic map of the atria compiled after merging data with a cardiac CT scan. This will be compared to standard invasive electro-anatomic mapping data collected during routine electrophysiology study and ablation.

The surface ECG vest will be fitted by trained study personnel (cardiac scientists, nurses, doctors) on a single occasion as per the product sizing and fitting guidelines. A cardiac CT scan will be performed once, (generally <30 minutes) with the vest worn, on the same day. Where there is a clinical indication for concomitant coronary artery assessment, iodinated contrast will be administered with the CT scan, in the same fashion and dose as would have been performed in the participant outside of this clinical study. The estimated dose of iodinated contrast for coronary assessment, if indicated, is 80-100mL. Data-merge with the CT scan and electrical data from the vest will take place over the next 1-2 hours, or less.

Participants will be selected from patients referred for electrophysiology study +/- ablation for atrial fibrillation or supraventricular tachycardia. Participants will undergo their clinically indicated electrophysiology study and ablation procedure, which does not differ in this study to standard practice. This study takes place in the cardiac electrophysiology laboratory and involves procedural sedation or general anaesthetic, with local anaesthetic to the right groin, where the procedural doctor will place sheaths, and through these sheaths, small catheters with electrodes on them. These catheters will be moved up to the heart and a puncture of the septum between the right and left upper chambers (atria) will be made, followed by passage of catheters to the left atrium. A dose of blood thinner (heparin) is routinely given at the point of crossing from the right to the left atrium. Mapping catheters will be passed into the left atrium and moved into contact with the atrial surface to collect the location in space and the voltage at the surface, which gives an indication of the health of the atrial muscle tissue. After electro-anatomic mapping has been performed, ablation will be performed using radio frequency energy to 'cauterise' specific areas of the atria. The ablation will vary depending on what rhythm is being treated and where the circuit is identified, but in general in atrial fibrillation involves a ring encompassing the pulmonary veins and part or all of the posterior atrial wall to electrically isolate these from the rest of the atria, and for supraventricular tachycardias, a smaller area of ablation is required to treat a focal source of the problem, or an area of slowly-conducting tissue or extra muscular connection that can be safely ablated to stop a circuit responsible for the rhythm problem. Atrial fibrillation or supraventricular tachycardia procedures including standard 3-dimensional electro-anatomic mapping utilising mapping catheters inside the heart and ablation will usually take between 1.5 and 2.5 hours to complete. The main difference from standard procedure for these arrhythmias in this study is that the pre-fitted surface mapping vest will be worn during the procedure.

After the procedure, the vest will be removed and the data from the electro-anatomic mapping and surface ECG mapping will be processed and compared offline. Participation in the study including the vest fitting, CT scan, electrophysiology study and ablation procedure will occur over around 5 hours on the same day.
Intervention code [1] 317963 0
Diagnosis / Prognosis
Comparator / control treatment
The 'control' in this study will be the clinically indicated electrophysiology study and ablation described above, and outlined again here, as follows. This study takes place in the cardiac electrophysiology laboratory and involves procedural sedation or general anaesthetic, with local anaesthetic to the right groin, where the procedural doctor will place sheaths, and through these sheaths, small catheters with electrodes on them. These catheters will be moved up to the heart and a puncture of the septum between the right and left upper chambers (atria) will be made, followed by passage of catheters to the left atrium. A dose of blood thinner (heparin) is routinely given at the point of crossing from the right to the left atrium. Mapping catheters will be passed into the left atrium and moved into contact with the atrial surface to collect the location in space and the voltage at the surface, which gives an indication of the health of the atrial muscle tissue. After electro-anatomic mapping has been performed, ablation will be performed using radio frequency energy to 'cauterise' specific areas of the atria. The ablation will vary depending on what rhythm is being treated and where the circuit is identified, but in general in atrial fibrillation involves a ring encompassing the pulmonary veins and part or all of the posterior atrial wall to electrically isolate these from the rest of the atria, and for supraventricular tachycardias, a smaller area of ablation is required to treat a focal source of the problem, or an area of slowly-conducting tissue or extra muscular connection that can be safely ablated to stop a circuit responsible for the rhythm problem. Atrial fibrillation or supraventricular tachycardia procedures including standard 3-dimensional electro-anatomic mapping utilising mapping catheters inside the heart and ablation will usually take between 1.5 and 2.5 hours to complete. The main difference from standard procedure for these arrhythmias in this study is that the pre-fitted surface mapping vest will be worn during the procedure.
Control group
Active

Outcomes
Primary outcome [1] 324298 0
Identification of unhealthy atrial tissue by surface ECG electro-anatomic mapping. Signals from the surface ECG vest will be compared to voltage collected from the invasive mapping where standard cutoffs for scar (<0.05 V) and intermediate voltage (o.05 - 0.5 V) tissue will be used.
Timepoint [1] 324298 0
Conclusion of study enrolment and signal processing for all participants (6 months).
Primary outcome [2] 324540 0
Identification of healthy atrial tissue by surface ECG electro-anatomic mapping. Signals from the surface ECG vest will be compared to voltage collected from the invasive mapping where standard cutoffs for healthy atrial tissue (>0.5 V) and other higher cutoffs known to correlate with potential areas of atrial remodelling will be explored.
Timepoint [2] 324540 0
Conclusion of study enrolment and signal processing for all participants (6 months).
Secondary outcome [1] 384276 0
Total time spent mapping and processing signals per participant via study specific time log of per-patient time spent.
Timepoint [1] 384276 0
Following signal processing of all study data, approximately 6 months following enrolment of the last participant.
Secondary outcome [2] 384935 0
Sensitivity will be determined by comparing the number of low voltage areas diagnosed by surface mapping compared to those diagnosed by the standard invasive mapping.
Timepoint [2] 384935 0
Following signal processing of all study data, approximately 6 months following enrolment of the last participant.
Secondary outcome [3] 384936 0
Specificity will be determined by comparing the number of normal voltage areas diagnosed by surface mapping compared to those diagnosed by the standard invasive mapping.
Timepoint [3] 384936 0
Following signal processing of all study data, approximately 6 months following enrolment of the last participant.

Eligibility
Key inclusion criteria
60 participants with a primary diagnosis of supraventricular tachycardia or atrial fibrillation referred for ablation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious underlying medical disorder
Age <18 years
Inability to provide informed consent
Moderate-severe valvular heart disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sensitivity, specificity, positive predictive value and negative predictive value of surface ECG diagnosis of normal versus low voltage areas will be calculated after comparison with the current accepted standard of invasive electro-anatomic mapping. This will be performed for various different atrial sites and voltage ranges used to define normal or abnormal atrial tissue.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2020
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
29/01/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16997 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 16998 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 16999 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [4] 17000 0
Ashford Community Hospital - Ashford
Recruitment postcode(s) [1] 30661 0
5000 - Adelaide
Recruitment postcode(s) [2] 30662 0
5011 - Woodville
Recruitment postcode(s) [3] 30663 0
5035 - Ashford

Funding & Sponsors
Funding source category [1] 306088 0
University
Name [1] 306088 0
Centre for Heart Rhythm Disorders, University of Adelaide
Country [1] 306088 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 306557 0
None
Name [1] 306557 0
Address [1] 306557 0
Country [1] 306557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306308 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 306308 0
Royal Adelaide Hospital
Port Road, Adelaide SA 5000
Ethics committee country [1] 306308 0
Australia
Date submitted for ethics approval [1] 306308 0
Approval date [1] 306308 0
27/01/2019
Ethics approval number [1] 306308 0
R20190107

Summary
Brief summary
The upper heart chambers (atria), particularly the left-atrium, can deteriorate with unhealthy changes in the heart muscle over time leading to abnormal electrical, structural and functional features, collectively termed 'atrial cardiomyopathy'. This process can progress to a significant extent without any direct symptoms, can thus go undetected, and contributes to increased risk of atrial fibrillation and stroke. Changes in the atria can be detected via measuring altered voltage in the heart muscle and changes in size and function on cardiac imaging.

This study will assess a new body-surface electrical signal ‘mapping’ strategy with a vest containing 252 surface electrodes, and a cardiac CT scan to assess electrical signals in the atria. This will be compared to the established procedure of mapping with catheters inside the heart in participants who are already undergoing heart mapping as part of a planned procedure. The hypothesis is that surface ECG mapping could be a useful, non-invasive method for detecting atrial cardiomyopathy without the need for invasive mapping.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103450 0
Prof Prashanthan Sanders
Address 103450 0
Centre for Heart Rhythm Disorders
University of Adelaide
North Terrace, Adelaide SA 5000
Country 103450 0
Australia
Phone 103450 0
+61 08 8222 2723
Fax 103450 0
Email 103450 0
[email protected]
Contact person for public queries
Name 103451 0
Dr John Fitzgerald
Address 103451 0
Centre for Heart Rhythm Disorders
University of Adelaide
North Terrace, Adelaide SA 5000
Country 103451 0
Australia
Phone 103451 0
+61 08 8313 9000
Fax 103451 0
Email 103451 0
[email protected]
Contact person for scientific queries
Name 103452 0
Prof Prashanthan Sanders
Address 103452 0
Centre for Heart Rhythm Disorders
University of Adelaide
North Terrace, Adelaide SA 5000
Country 103452 0
Australia
Phone 103452 0
+61 08 8313 9000
Fax 103452 0
Email 103452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.