Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001235695
Ethics application status
Approved
Date submitted
2/11/2023
Date registered
30/11/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The ElectroPulse Study: A Safety and Feasibility Study of the ElectroPulse Pulsed Field Ablation (PFA) System to Treat Atrial Fibrillation.
Scientific title
The ElectroPulse Study: A Safety and Feasibility Study of the ElectroPulse Pulsed Field Ablation (PFA) System to Treat Patients with Atrial Fibrillation.
Secondary ID [1] 308813 0
P0683
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 328772 0
Condition category
Condition code
Cardiovascular 325780 325780 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.
No ablation will be performed at the Remap Procedure unless there is documented clinical recurrence of AF. Data will continue to be collected from these Participants who undergo repeat ablation.

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.

Remap Procedure
The Remap Procedure is an additional cardiac mapping procedure (“re-mapping”), performed 3-6 months after the initial cardiac ablation procedure (Index Procedure), to assess how effective the Index Procedure with the ElectroPulse PFA System was.

The preparation and progress of the Remap Procedure are identical to the Index Procedure or 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 atrial fibrillation. This is done by guiding a commercially available diagnostic catheter (tube) into the heart via a small hole in the groin. The only difference is that no ablation therapy is reapplied or delivered unless required.

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.

An independent Contract Research Organisation (CRO) has been employed to monitor the study. The CRO will review all data collected from the source medical records held. The CRO will ensure the study is followed per protocol and all local regulations.
Intervention code [1] 325265 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333654 0
Primary composite feasibility endpoint:
Proportion of participants that achieve acute procedural success. Acute procedural success will be defined as pulmonary vein isolation using ElectroPulse PFA System confirmed with the significant attenuation or diminished pulmonary venous electrograms and achieving bidirectional block in the pulmonary veins. Bidirectional block is tested and confirmed by pacing manoeuvres and three-dimensional electro-anatomical mapping post-ablation during the Index Procedure.
Acute procedural success will be defined by the demonstration of acute isolation of the pulmonary veins demonstrated by:
1. Entrance block
2. Exit block
3. Adenosine use
4. 30-minute waiting period
Timepoint [1] 333654 0
3 months post-procedure
Primary outcome [2] 333905 0
Primary composite safety endpoint:
Demonstrate an acceptable safety profile of PVI ablation with the ElectroPulse PFA System. Adverse events that are reported will be evaluated and assessed by the Study’s Clinical Events Committee (CEC) using medical records that are collected for each event. The CEC members are independent and do not have any interest in the study. The following Investigational Device-related and procedure-related serious adverse events (SAEs) will be considered a primary safety event per the CEC's decision:

Within 7 days post-ablation:
• Death
• ST Elevation Myocardial Infarction (STEMI)
• Phrenic nerve palsy /Diaphragmatic paralysis
• Transient Ischemic Attack (TIA)
• Stroke/Cerebrovascular accident (CVA)
• Thromboembolism
• Pericarditis requiring pericardiocentesis (major)
• Cardiac tamponade/perforation
• Pneumothorax
• Vascular Access Complications requiring intervention.
• Pulmonary embolism requiring intervention.
• Pulmonary oedema
• Prolonged hospitalisation following the index procedure or re-admission (excluding hospitalisation due to recurrent AF/AFL/AT or non-urgent cardioversion)
• Atrio-ventricular node conduction block

Within 6-months post-ablation:
• Pulmonary vein (PV) stenosis (equal to 70% diameter reduction)
• Phrenic nerve palsy/diaphragmatic paralysis (ongoing at 6 months)
• Atrio-oesophageal fistula
Timepoint [2] 333905 0
7 days post-procedure and 6 months post-procedure
Secondary outcome [1] 417869 0
Secondary composite feasibility endpoints:
The secondary feasibility endpoint(s) include the proportion of participants that achieve reasonable chronic procedural success.
Chronic procedural success is defined as freedom from secondary procedural failure or recurrence of AF. Secondary procedural failure is defined as the occurrence of any of the following:
1. Electrical reconnection of the pulmonary veins assessed during an electro-anatomical mapping procedure performed 3-6 months following the index procedure.
2. Documented AF/AT/AFL between 3-12 months post ablation.
3. Any subsequent AF surgery or ablation in the left atrium between 3-12 months post ablation.
4. Direct current cardioversion for atrial tachyarrhythmia between 3-12 months post ablation.
5. Class I or III antiarrhythmic drug (AAD) dose increase from the historic maximum ineffective dose (prior to the ablation procedure) or initiation of a new Class I or III AAD between 3-12 months post ablation.
Timepoint [1] 417869 0
3-12 months post-procedure
Secondary outcome [2] 418667 0
Secondary safety endpoint:
The proportion of participants reporting one or more -Investigational Device-related and procedure-related SAEs for each follow-up interval such as:
Phrenic nerve palsy /Diaphragmatic paralysis – assessed using ultrasound
Transient Ischemic Attack (TIA) – assessed using brain MRI
Stroke/Cerebrovascular accident (CVA) – assessed using various tests including brain MRI, ECG, blood tests
Thromboembolism – assessed using ultrasound and brain MRI
Pericarditis requiring pericardiocentesis (major) – blood tests, ECG, chest x-ray, chest ultrasound, chest CT or MRI
Cardiac tamponade/perforation blood tests, ECG, chest x-ray, chest ultrasound, chest CT or MRI
Pneumothorax - blood tests, ECG, chest x-ray, chest ultrasound, chest CT or MRI
Vascular Access Complications requiring intervention – assessed using blood tests, x-ray, ultrasound
Pulmonary embolism requiring intervention - ECG, chest x-ray, chest ultrasound, chest CT or MRI
Pulmonary oedema - , ECG, chest x-ray, chest ultrasound, chest CT or MRI
Atrio-ventricular node conduction block – ECG, EP Study
Pulmonary vein (PV) stenosis (greater than or equal to 70% diameter reduction) – assessed using chest CT, blood pressure monitor
Atrio-oesophageal fistula – assessed using CT, IV contrast, blood tests
Timepoint [2] 418667 0
• The Index ablation procedure to the Day 7 follow-up visit;
• The Day 7 follow-up visit to the Month 3 follow- up visit;
• The Month 3 follow-up visit to the Month 6 follow- up visit;
• The Month 6 follow-up visit to the Month 9 follow-up visit; and
• The Month 9 follow-up visit to the Month 12 follow-up visit.

Eligibility
Key inclusion criteria
Inclusion Criteria:
All participants are required to meet all the following inclusion criteria to be considered eligible for participation in this study:
1. Age > 18
2. Able to provide written consent.
3. Paroxysmal or persistent atrial fibrillation meeting the criteria for ablative intervention based on the current guidelines:
3.1. Participants who have failed at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic paroxysmal or persistent AF, or intolerable side effects due to AAD.
3.2. 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 7 days of onset, documented by the following:
i) Physician's note indicating at least 1 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrolment; and
ii) at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrolment. Documentation may include ECG, Holter monitor or telemetry strip OR
b) Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
i) Physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrolment; and
ii) any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrolment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrolment. Documentation may include ECG, Holter monitor or telemetry strip.
4. Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception from baseline to the six-month follow-up visit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
1. Secondary AF- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause such as acute alcohol toxicity
2. Long-standing persistent or permanent AF (continuous AF that is sustained >12 months)
3. Patient with previous ablation or surgery for AF
4. Patient with a prosthetic heart valve
5. History of congenital heart disease with any residual anatomic or conduction abnormality
6. History of abnormal bleeding and/or clotting disorder.
7. Active malignancy or history of treated cancer within 24 months of enrolment.
8. Clinically significant current infection or sepsis.
9. History of any cerebral ischemic events (stroke or TIA) or thromboembolic events or evidence of intracardiac thrombus at the time of the procedure.
10. New York heart Association (NYHA) function class IIIb or IV congestive heart failure and/or any heart failure hospitalisation within 3 months prior to enrolment.
11. Body mass index > 40 Kg/m2.
12. Estimate glomerular filtration rate (eGFR) < 35 mL/min/1.73 m2 or has ever received renal dialysis or transplant.
13. Any of the following within 3 months of enrolment:
13.1. Major surgery
13.2. Myocardial infarction or unstable angina
13.3. Any coronary intervention (e.g. Percutaneous coronary intervention)
13.4. Aborted sudden cardiac death.
13.5. Left atrial thrombus that has not resolved as shown by trans-oesophageal echocardiogram (TOE) or computerized tomography (CT) scan.
13.6. Implantation of permanent pacemaker implanted cardiac defibrillator, or cardiac resynchronisation therapy.
14. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant.
15. History of pulmonary hypertension with Pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease.
16. Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulopathy).
17. Patients with hemodynamically significant valvular disease, atrial or ventricular septal defect closure, pulmonary vein stenosis, atrial myxoma and/or significant or symptomatic hypotension.
18. Life expectancy less than one year.
19. Contraindication to anticoagulation (i.e., heparin, direct acting oral anticoagulation, Vitamin K Antagonist).
20. Hypertrophic cardiomyopathy
21. Patients who are unable to undergo brain MRI
22. Women who are currently pregnant or planning on becoming pregnant within six months of being on the study.
23. Patients who are unable to provide informed consent or unwilling or unable to comply fully with study procedures and follow-up.
24. Enrolled in another cardiac clinical study that would interfere with this study.

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
The study is a feasibility study with no formal hypothesis testing and therefore no required sample size. Study results will be presented using descriptive statistics. Results from this study will be used to design additional clinical studies. For continuous variables, the summary will include number, mean, and standard deviation and 95% confidence intervals. Summaries for categorical variables will include the number and percentage of participants in each category.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23885 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 39349 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313033 0
Commercial sector/Industry
Name [1] 313033 0
CathRx Ltd
Country [1] 313033 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CathRx Ltd
Address
8/2/8 South StRydalmere NSW 2116
Country
Australia
Secondary sponsor category [1] 314721 0
None
Name [1] 314721 0
Address [1] 314721 0
Country [1] 314721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312290 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 312290 0
Ethics committee country [1] 312290 0
Australia
Date submitted for ethics approval [1] 312290 0
15/02/2023
Approval date [1] 312290 0
15/03/2023
Ethics approval number [1] 312290 0
2023/HRE00036

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

Contacts
Principal investigator
Name 124126 0
Prof Prashanthan Sanders
Address 124126 0
Royal Adelaide Hospital and Centre for Heart Rhythm Disorders Port Rd Adelaide SA 5000
Country 124126 0
Australia
Phone 124126 0
+61 8 8313 9014
Fax 124126 0
Email 124126 0
[email protected]
Contact person for public queries
Name 124127 0
Simi Khan
Address 124127 0
Cardiovascular Centre 62 Beulah Rd, Norwood SA 5067
Country 124127 0
Australia
Phone 124127 0
+61 8 8313 9014
Fax 124127 0
+61 8 8362 2273
Email 124127 0
[email protected]
Contact person for scientific queries
Name 124128 0
Prashanthan Sanders
Address 124128 0
Royal Adelaide Hospital and Centre for Heart Rhythm Disorders Port Rd Adelaide SA 5000
Country 124128 0
Australia
Phone 124128 0
+61 883139000
Fax 124128 0
Email 124128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Listings of all de-identified data
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Case by case basis after written permission is sought from the Sponsor.
Available for what types of analyses?
On a case by case basis after written permission is sought form the Sponsor.
How or where can data be obtained?
Directly from the Sponsor on a case by case basis if made in writing to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18164Ethical approval  [email protected] Approval from the NHMRC approved Ethics Committee.



Results publications and other study-related documents

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