Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001523796
Ethics application status
Approved
Date submitted
28/09/2022
Date registered
8/12/2022
Date last updated
23/06/2024
Date data sharing statement initially provided
8/12/2022
Date results information initially provided
23/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of electroporation for cardiac ablation in patients with atrial fibrillation
Scientific title
Rapid OnE-Shot Electroporation Trial for Atrial Fibrillation: RESET-AF: Investigating the effect of a novel intervention on atrial fibrillation recurrence
Secondary ID [1] 308056 0
CLP001
Universal Trial Number (UTN)
Trial acronym
RESET-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial tachyarrhythmia 327749 0
Condition category
Condition code
Cardiovascular 324821 324821 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Catheter ablation is an atrial fibrillation treatment that is done by a specialized cardiologist, called an electrophysiologist (EP), who deals with irregular heartbeats (arrhythmias).
It is a minimally-invasive procedure that is generally less invasive than surgery. It is a commonly-used treatment for atrial fibrillation as well as other cardiac arrhythmias.
It is done on a beating heart in a closed chest procedure. Small punctures are made in the groin and the catheters, are inserted and threaded to the heart. Once there, the catheter's tip is threaded through a tiny incision in the wall between the left and right atria (septal wall), and is positioned to ablate tissue around the pulmonary veins or at other sources of erratic electrical signals that cause the irregular heartbeat.
The catheter uses an energy source, such as radio frequency energy (radio waves) to create a lesion of scar tissue, called a conduction block, that stops the erratic electrical signals from travelling through the heart.
The procedure usually takes around 2 to 4 hours per patient.
The ElePulse system which is used in this study is an electroporation ablation system. It uses pulsed field energy to selectively destroy cardiac tissue and thus stop aberrant electric conduction in the heart. This is called Pulsed Field Ablation (PFA). The ElePulse catheter is connected to the ElePulse PFA generator which creates the electric field used to ablate the heart tissue.
A remap procedure will be performed at 3 months after the completion of the ablation procedure. During this procedure it will be determined whether the success of the first procedure was durable. The remap procedure is comparable in duration to the initial procedure. If the first procedure is not considered adequate, a re-ablation may be performed during the remap procedure.
Intervention code [1] 324505 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332636 0
Freedom from recurrent AF will be assessed at 6 and 12 months via Holter monitoring
Timepoint [1] 332636 0
At 12 months post procedure
Primary outcome [2] 332637 0
Ablation system-related serious adverse events (SAEs) for instance atrial-esophageal fistula, cardiac tamponade/perforation, bleeding, death, phrenic nerve injury etc. assessed by clinical evaluation
Timepoint [2] 332637 0
Any adverse events that occur within the first 7 days after the procedure
Primary outcome [3] 332638 0
Procedure (but not system) related SAEs for example gastric motility disorder, myocardial infarction, pericarditis, pulmonary vein stenosis, stroke or transient ischemic attack assessed by clinical examination, patient reports of their symptoms
Timepoint [3] 332638 0
Any adverse events that occur within the first 30 days post procedure
Secondary outcome [1] 414171 0
The chronic safety of the ElePulse system will be assessed by evaluating the nature and frequency of adverse events (AE) for example gastric motility disorder, myocardial infarction, pericarditis, pulmonary vein stenosis, stroke or transient ischemic attack assessed by clinical examination, patient reports of their symptoms.
Timepoint [1] 414171 0
At 30 days, 3 months, 6 months and 12 months post-procedure
Secondary outcome [2] 416425 0
The chronic safety of the ElePulse system will be assessed by evaluating the nature and frequency of adverse device effects (ADE) for instance atrial-esophageal fistula, cardiac tamponade/perforation, bleeding, death, phrenic nerve injury etc. assessed by clinical evaluation
Timepoint [2] 416425 0
At 30 days, 3 months, 6 months and 12 months post-procedure

Eligibility
Key inclusion criteria
Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
History of recurrent symptomatic paroxysmal atrial fibrillation (AF)
At least one episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
Refractory to at least one Class I - IV anti-arrhythmic drug (AAD)
Competent and willing to provide written informed consent to participate in the study and agree to comply with the follow-up visits and evaluation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous left atrial ablation procedure
Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
Known severe cerebrovascular disease or history of cerebrovascular event (within 1 month)
Patients with severely impaired kidney function
Active gastrointestinal bleeding
Active infection or fever
Sepsis
Cardiac surgery within the past two months
Short life expectancy (< 1yr) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease
Significant anemia
Severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the last 30 days)
Documented anaphylaxis during previous exposure to angiographic contrast media

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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
8/02/2023
Date of last participant enrolment
Anticipated
30/12/2023
Actual
6/12/2023
Date of last data collection
Anticipated
6/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 23228 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 23669 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 39095 0
2145 - Westmead
Recruitment postcode(s) [2] 38596 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 312312 0
Commercial sector/Industry
Name [1] 312312 0
BIOTRONIK Australia Pty Ltd
Country [1] 312312 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BIOTRONIK Australia Pty Ltd
Address
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 313866 0
None
Name [1] 313866 0
Address [1] 313866 0
Country [1] 313866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311801 0
Metro South Health HREC
Ethics committee address [1] 311801 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [1] 311801 0
Australia
Date submitted for ethics approval [1] 311801 0
12/10/2022
Approval date [1] 311801 0
21/12/2022
Ethics approval number [1] 311801 0
HREC/2022/QMS/90699

Summary
Brief summary
The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the ElePulse electroporation ablation system. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121974 0
A/Prof Paul Gould
Address 121974 0
Metro South Hospital and Health Service via
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane QLD 4102
Country 121974 0
Australia
Phone 121974 0
+61 408773975
Fax 121974 0
Email 121974 0
drpgould@gmail.com
Contact person for public queries
Name 121975 0
A/Prof Paul Gould
Address 121975 0
Metro South Hospital and Health Service via
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane QLD 4102
Country 121975 0
Australia
Phone 121975 0
+61 408773975
Fax 121975 0
Email 121975 0
drpgould@gmail.com
Contact person for scientific queries
Name 121976 0
A/Prof Paul Gould
Address 121976 0
Metro South Hospital and Health Service via
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, Brisbane QLD 4102
Country 121976 0
Australia
Phone 121976 0
+61 408773975
Fax 121976 0
Email 121976 0
drpgould@gmail.com

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


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.