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Trial registered on ANZCTR


Registration number
ACTRN12625000851460
Ethics application status
Approved
Date submitted
23/07/2025
Date registered
6/08/2025
Date last updated
6/08/2025
Date data sharing statement initially provided
6/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
ElectroPulseTM Pulsed Field Ablation System to Treat Atrial Fibrillation
Scientific title
A prospective, multinational, non-randomised, open label clinical study to assess the efficacy and characterise the safety of the ElectroPulseTM Pulsed Field Ablation System to treat Atrial Fibrillation
Secondary ID [1] 314968 0
P0696
Universal Trial Number (UTN)
U1111-1325-6438
Trial acronym
ELECTROPULSE AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Atrial Fibrillation (AF) 338280 0
Paroxysmal Atrial Fibrillation (AF) 338281 0
Condition category
Condition code
Cardiovascular 334584 334584 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ElectroPulse Pulsed Field Ablation (PFA) System is a medical device which is used to perform cardiac catheter ablation. The ElectroPulse PFA System consists of the following components: (1) ElectroPulse Pulsed Field Ablation Generator, (2) ElectroPulse Pulsed Field Ablation Catheters, (3) ElectroPulse Pulsed Field Ablation Extension Cable.

Index Procedure
At index procedure a specialist cardiologist called an electrophysiologist guides a tube called a catheter into the patient heart and uses energy to ablate (i.e. remove) small areas of tissue/nerves responsible for creating the faulty electrical signals that may be causing the irregular heartbeat or atrial fibrillation. The procedure is carried out in an operating room under full anaesthesia and takes 1-4 hours. The procedure preparation and progress are identical to all standard catheter ablation procedures currently performed for atrial fibrillation. During the procedure, the heart will also be ‘mapped’ in a 3D manner, which is a procedure to assess the electrical function of the heart to help the clinical team locate what region of the heart is causing faulty electrical signals in the heart and contributing to the patient's atrial fibrillation. This is done by guiding a commercially available diagnostic catheter (tube) into the heart via a hole in the groin. The experimental component of the study is the use of the ElectroPulse PFA System to undertake the ablation aspect of the procedure.

Reablation Procedure
If a participant continues to experience atrial fibrillation symptoms within 60 days, and the investigator deems it necessary, the participant will undergo a Remap Procedure to assess whether the initial ablation procedure was successful and new areas of arrhythmia have been formed, or if the initial procedure was unsuccessful. If the cardiac electrophysiologist believes it is required, a commercial device will be used to perform additional ablations.

The Remap Procedure is carried out in an operating room under full anaesthesia by a cardiac electrophysiologist (usually the same doctor that perform the Index Procedure) and may take 1-4 hours.

Procedural data will be captured in Case Report Forms by the study team, and will include the location and number of ablations performed. Cases will also be video recorded with the consent of the participant for case review in the future.

The study will enroll three separate cohorts for regulatory purposes:
1. Persistent AF Cohort – Up to 150 participants diagnosed with persistent atrial fibrillation.
2. Paroxysmal AF Cohort – Up to 150 participants diagnosed with paroxysmal atrial fibrillation.
3. Roll-in Cohort – Up to 100 participants who will be the first treated by each investigator to allow familiarisation with the procedure or device.
Although these cohorts are defined separately for regulatory tracking, all participants will be analysed together in the overall study analysis.
Intervention code [1] 331561 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342255 0
The primary safety endpoint is the occurrence of any of the below procedure or device related serious adverse events Events experienced within 6 months of an investigational ablation procedure: • Pulmonary vein stenosis (greater than or equal to 70% diameter reduction) • Phrenic nerve injury/diaphragmatic paralysis (ongoing at 6 months) • Atrioesophageal fistula Events experienced within 30 days of an investigational ablation procedure: • Cardiac tamponade/perforation • Stroke/Cerebrovascular accident • Major bleeding requiring transfusion • Myocardial infarction • Pericarditis requiring intervention • Transient ischemic attack • Vagal nerve injury resulting in oesophageal dysmotility or gastroparesis • Vascular access complication requiring intervention • Systemic/pulmonary embolism requiring intervention • Thromboembolism • Pulmonary oedema • Death • Acute renal failure resulting from hemoglobinuria and hemolysis • Coronary artery spasm • Atrioventricular (AV) Node conduction block • Any device or procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalisation for more than 48 hours (excluding hospitalisation solely for arrhythmia recurrence or non-urgent cardioversion)
Timepoint [1] 342255 0
Procedure or device related serious adverse events reported within six months of the investigational procedure.
Primary outcome [2] 342256 0
The primary efficacy endpoint is treatment success, defined as freedom from treatment failure.
Timepoint [2] 342256 0
Within 60 days of the initial ablation procedure
Secondary outcome [1] 450145 0
Change in quality of life
Timepoint [1] 450145 0
Collect at baseline, 60 days, 6 months and 12 months post initial ablation procedure.
Secondary outcome [2] 450146 0
Change in Atrial Fibrillation Effect on Quality of Life
Timepoint [2] 450146 0
Collect at baseline, 60 days, 6 months and 12 months post initial ablation procedure.

Eligibility
Key inclusion criteria
All participants are required to meet all the following inclusion criteria to be considered eligible for participation in this study:
1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
2. Age between 18 and 80 at the time of informed consent (or older than 18 if required by local law).
3. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
a) Symptomatic paroxysmal AF which is defined as AF that terminates spontaneously or with intervention within seven days of onset, documented by the following:
i) Physician’s note indicating at least two symptomatic paroxysmal AF episodes occurring within six months prior to enrolment; and
ii) At least one ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrolment (can include episodes recorded on a validated wearable).
OR
b) Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than one year, documented by the following:
i) Physician’s note indicating at least one symptomatic persistent AF episode occurring within six months prior to enrolment; and
ii) Any 24-hour continuous ECG recording documenting continuous AF within six months prior to enrolment; OR
Two ECGS from any form of rhythm monitoring taken at least seven days apart, both showing continuous AF within six months prior to enrolment (can include episodes recorded on a validated wearable).
4. Able and willing to comply with all trial requirements including pre-procedure, post-procedure and follow up testing and requirements
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from participating in this study if they meet any one of the following exclusion criteria:
1. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnoea, and acute alcohol toxicity
2. Long-standing persistent or permanent AF (continuous AF that is sustained greater than 12 months)
3. Previous left atrial ablation or surgical procedure
4. Left atrial diameter greater than 5.5 cm (anteroposterior) measured within 180 days of index procedure
5. Presence of an implanted LAA closure device, permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function). Note that presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device
6. Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without pacing function) for any time during the follow-up period
7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) or valve or coronary bypass grafting surgery within 90 days of the consent date
8. Pre-existing stent, constriction or stenosis in a pulmonary vein
9. Presence of any cardiac valve prosthesis
10. Rheumatic heart disease
11. Severe mitral regurgitation (regurgitant volume greater than or equal to 60 mL/beat, regurgitant fraction greater than or equal to 50%, and/or effective regurgitant orifice area greater than or equal to 0.40cm2).
12. Moderate to severe mitral stenosis (mitral valve area of less than 1.5cm2) calculated from the screening echocardiogram
13. Severe atrial dilation defined by a Left Atrial Volume Index (LAVI) of less than or equal to 50mL/m2 calculated from the screening echocardiogram
14. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
15. Unstable angina
16. Active systemic infection
17. History of any cerebral ischemic events (stroke or TIA) or thromboembolic events or evidence of intracardiac thrombus within six months of the date of consent
18. New York heart Association (NYHA) function class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. TTE)
19. Body mass index greater than 40 Kg/m2.
20. Estimate glomerular filtration rate (eGFR) less than 35 mL/min/1.73 m2 or has ever received renal dialysis or transplant.
21. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lunge or respiratory system that produces severe chronic symptoms including, but not limited to primary pulmonary hypertension (defined as pulmonary systolic artery pressure greater than 50mm Hg)
22. Any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, or significant coagulopathy).
23. Hemodynamically significant valvular disease, atrial or ventricular septal defect closure, atrial myxoma and/or significant or symptomatic hypotension.
24. Life expectancy less than one year.
25. Contraindication to anticoagulation (i.e., heparin, direct acting oral anticoagulation, Vitamin K Antagonist).
26. Hypertrophic cardiomyopathy
27. Women who are currently pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
28. Presence of other medical, anatomic, comorbid, social or psychological conditions that, in the investigator’s opinion, could limit the participant’s ability to participate in the clinical investigation or comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
29. Unable to provide informed consent or unwilling or unable to comply fully with study procedures and follow-up.
30. Current or anticipated enrolment in another clinical trial of a drug, device or biologic during the duration of the study not pre-approved by CathRx

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 300 participants (150 persistent AF and 150 paroxysmal AF) ensures both safety and efficacy endpoints can be appropriately characterised. Other recently published PFA studies assess safety with a one-sided test where the probability of an event through 6 months is 13%.
The study has adopted the efficacy assessments from the 2017 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation recommends a probability of treatment success of greater than 50% for paroxysmal AF and greater than 40% for persistent AF at 12 months.
For regulatory purposes the study will enroll three separate cohorts. Two cohorts will have a sample size of up to 300 participants each (150 persistent AF and 150 paroxysmal AF). The third cohort will be a roll in group of up to 100 participants. The roll in participants will be the first treated participants per investigator.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28230 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 28231 0
Ashford Community Hospital - Ashford
Recruitment postcode(s) [1] 44441 0
5000 - Adelaide
Recruitment postcode(s) [2] 44442 0
5035 - Ashford

Funding & Sponsors
Funding source category [1] 319522 0
Commercial sector/Industry
Name [1] 319522 0
CathRx Ltd
Country [1] 319522 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CathRx Ltd
Address
Country
Australia
Secondary sponsor category [1] 322022 0
None
Name [1] 322022 0
Address [1] 322022 0
Country [1] 322022 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318096 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 318096 0
Ethics committee country [1] 318096 0
Australia
Date submitted for ethics approval [1] 318096 0
17/02/2025
Approval date [1] 318096 0
16/04/2025
Ethics approval number [1] 318096 0
2025/HRE00044

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

Contacts
Principal investigator
Name 143106 0
Prof Prashanthan Sanders
Address 143106 0
Cardiovascular Centre 62 Beulah Rd, Norwood SA 5067
Country 143106 0
Australia
Phone 143106 0
+61883139000
Fax 143106 0
Email 143106 0
[email protected]
Contact person for public queries
Name 143107 0
Mr Lachlan Porter
Address 143107 0
CathRx, Unit 8, 2 South St, Rydalmere NSW 2116
Country 143107 0
Australia
Phone 143107 0
+61278041846
Fax 143107 0
Email 143107 0
[email protected]
Contact person for scientific queries
Name 143108 0
Mr Lachlan Porter
Address 143108 0
CathRx, Unit 8, 2 South St, Rydalmere NSW 2116
Country 143108 0
Australia
Phone 143108 0
+61278041846
Fax 143108 0
Email 143108 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.