Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001335583
Ethics application status
Approved
Date submitted
21/10/2024
Date registered
4/11/2024
Date last updated
4/11/2024
Date data sharing statement initially provided
4/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Portable trans-oesophageal ElectroPhysiological (EP) Study
Scientific title
A Pilot EP study to collect preliminary safety & qualitative device performance data in humans (eg: electrogram quality, pace capture quality, device usability, overall diagnostic use experience, patient comfort etc) of a novel portable and fully integrated stimulator and ECG recorder for the purpose of esophageal atrial pacing and sensing to manage and diagnose SVT arrhythmias
Secondary ID [1] 313220 0
Nil
Universal Trial Number (UTN)
Trial acronym
Portable TEEP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Rhythm Disorder 335518 0
Condition category
Condition code
Cardiovascular 332083 332083 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TEEPS will be performed by qualified cardiologist aided by medical staff trained in passing nasogastric tubes and according to the FIABâ„¢ oesophageal catheter instruction and safety information. All the procedure data will be maintained in the timely manner on patient as well as proceduarl data questionnaire sheet.
Intervention is the physician’s choice to use the OneStim TEEPS procedure (OneStim CE approved) on a patient who has either given full medical consent to undergo a cardiac electrophysiology procedure or presented to the emergency department with a suspected SVT.
o The 5 lead surface ECG (sECG) wires from the OneStim will be connected to the patient.
o A 7F esophageal pacing catheter is lubricated with xylocaine gel and slowly advanced into the esophagus via the nose. Once in place the catheter will be taped in place.
o Recordings will be made of the heart rhythm from the catheter in the esophagus
o Pacing of the heart will be performed via the catheter in the esophagus
o The intention of the pacing will be to possibly induce and diagnose any heart arrhythmia
o The procedure will be finished when an arrhythmia is identified or when the pacing protocol is complete and no arrhythmia is induced.
o At completion of the procedure the catheter will be withdrawn from the nose
o The procedure is expected to last approximately 15-30 minutes
o The patient will then undergo the intracardiac electrophysiology study
o There is no follow up required
Prior to the commencement of the intracardiac electrophysiology procedure, the patient will undergo the OneStim TEEPS procedure. This procedure is expected to last no longer than 30 minutes. For patients presenting to the Emergency Department, the OneStim TEEPS procedure will be performed in the Emergency Department. A trans-oesophageal catheter will be introduced into the oesophagus via the nose. Pacing of the atria will be performed to induce tachycardia. Measurements will be recorded throughout the procedure.

During the procedure the patient’s vital signs including heart rate, blood pressure, pulse oximetry and respiratory rate will be monitored. Post completion of The OneStim TEEPS procedure the patient will continue with their care as previously arranged (either proceeding with an electrophysiology study or emergency department care). The patient’s vital signs will continue to be monitored during the post procedure period according to usual department protocols. The patient experience with the OneStim TEEPS procedure will be captured using proceduralist and patient questionnaire.
Intervention code [1] 329794 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group; Standard of care- the patient will be admitted to the hospital for the diagnostic electrophysiology procedure as usual and undergo the EP study as planned
Control group
Active

Outcomes
Primary outcome [1] 339673 0
Proportion of technically successful TEEPS studies
Timepoint [1] 339673 0
Procedure Response: At the time of conclusion
Primary outcome [2] 339675 0
Successful identification of HIS bundle potential using signal averaging
Timepoint [2] 339675 0
Procedure Response: Monitored throughout the duration of procedure
Primary outcome [3] 339676 0
OneStim’s ability to induce and terminate SVT in those with inducible SVT on intra-cardiac EPS This will be assessed as a composite outcome
Timepoint [3] 339676 0
Procedure At conclusion of procedure
Secondary outcome [1] 440877 0
Freedom from unacceptable discomfort or pain from TEEPS
Timepoint [1] 440877 0
Post procedure

Eligibility
Key inclusion criteria
Patients with palpitations or syncope suspected or documented to be due to SVT and either:
• Scheduled for a diagnostic ± ablation intracardiac electrophysiology procedure
• Considered for diagnostic ± ablation intracardiac electrophysiology procedure, in patients who have presented to the Emergency Department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with previous pharynx or oesophageal surgery
• Acute upper respiratory tract inflammation.
• Large aortic aneurysm.
• Severe oesophageal disease.
• Any disease or disorder which would lead to the patients intolerance to oesophageal catheter insertion
• Women who are pregnant
• Children/young people under 18 years old
• Patients who are highly dependent on medical care who may be unable to give consent
• Patients with cognitive impairment, intellectual disability or mental illness
• Patients in in dependent or unequal relationships

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27256 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 43343 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317663 0
Commercial sector/Industry
Name [1] 317663 0
Micropace Pty Ltd
Country [1] 317663 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319976 0
None
Name [1] 319976 0
Address [1] 319976 0
Country [1] 319976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316361 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316361 0
Ethics committee country [1] 316361 0
Australia
Date submitted for ethics approval [1] 316361 0
03/08/2023
Approval date [1] 316361 0
09/11/2023
Ethics approval number [1] 316361 0
2023/HRE00072

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137650 0
Prof Prash Sanders
Address 137650 0
Center for Heart Rhythm Disorders, University of Adelaide; 62, Beulah Road, Norwood, SA 5067
Country 137650 0
Australia
Phone 137650 0
+61 8 83139012
Fax 137650 0
Email 137650 0
[email protected]
Contact person for public queries
Name 137651 0
Simi Khan
Address 137651 0
Center for Heart and Rhythm disorders, University of Adelaide; 62, Beulah Rd, Norwood, SA5067
Country 137651 0
Australia
Phone 137651 0
+61 0883139012
Fax 137651 0
Email 137651 0
[email protected]
Contact person for scientific queries
Name 137652 0
Dr Shaun Evans
Address 137652 0
Center for Heart Rhythm Disorders, University of Adelaide; 62 beulah Rd, Norwood, SA, 5067
Country 137652 0
Australia
Phone 137652 0
+61 0883139000
Fax 137652 0
Email 137652 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.