Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001306505
Ethics application status
Approved
Date submitted
2/10/2024
Date registered
28/10/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulsed-field ablation vs radio-frequency ablation for recurrent atrial fibrillation.
Scientific title
Comparing rates of acute posterior wall isolation in patients undergoing repeat atrial fibrillation ablation using pulsed-field vs radiofrequency ablation.
Secondary ID [1] 313097 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent atrial fibrillation 335340 0
Condition category
Condition code
Cardiovascular 331930 331930 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Elective repeat AF ablation with pulsed field technology
Patients with recurrent AF in this arm will be treated with pulsed-field ablation using the Farapulse system from Boston Scientific. Patients will undergo isolation of the pulmonary veins and posterior wall using the Farawave ablation catheter. The number of applications during the procedure and dose is pre-specified/as per manufacturer recommendations (2Hz, 4 applications in "flower" configuration, 4 applications in "basket" configuration per pulmonary vein; however, further applications can be delivered as the discretion of the operator). This is performed by an electrophysiologist. There is only 1 session (the procedure). Each session is approximately 2-3 hours
Intervention code [1] 329657 0
Treatment: Devices
Comparator / control treatment
Repeat AF ablation using radiofrequency ablation technology
Patients with recurrent AF in this arm will be treated with point-by point radiofrequency ablation using electroanatomical mapping systems (standard practice). A detailed 3-dimensional, electroanatomical map (3D-EAM) will be generated in all patients (CARTO3™, Biosense Webster or Rhythmia-HDx™, Boston Scientific or EnSite Precision™, Abbott mapping systems) with a multispline catheter (OctaRay, Biosense Webster, or Orion, Boston Scientific, or Advisor™ HD Grid mapping catheters). The choice of software and mapping catheter is based on the electrophysiologist's usual practice. Patients will undergo isolation of the pulmonary veins and posterior wall using a 4mm irrigated ablation catheter that is compatible with the chosen electroanatomical mapping software. The energy delivered will vary between manufacturer recommendations, but is generally 40-50watts of power. This is performed by an electrophysiologist. There is only 1 session (the procedure). Each session is approximately 2-3 hours
Control group
Active

Outcomes
Primary outcome [1] 339528 0
Acute posterior wall isolation as assessed using ablation and mapping catheters at the end of the procedure (see below)
Timepoint [1] 339528 0
At the end of the procedure.
Secondary outcome [1] 440346 0
Acute pulmonary vein isolation
Timepoint [1] 440346 0
At the end of the procedure.
Secondary outcome [2] 440347 0
Atrial fibrillation recurrence
Timepoint [2] 440347 0
3-months and 12-months post randomised ablation procedure
Secondary outcome [3] 440348 0
Atrial physiology
Timepoint [3] 440348 0
3-months post randomised ablation procedure
Secondary outcome [4] 440349 0
Procedural metrics
This will be assessed as a composite outcome.
Timepoint [4] 440349 0
At the end of the procedure

Eligibility
Key inclusion criteria
• Age between 18-80 years
• Paroxysmal or persistent atrial fibrillation (persistent AF < 3 years)
• Referred for a repeat atrial fibrillation ablation (AFA) following an AF recurrence which has occurred more than 6 weeks after previous AFA, provided the only ablation preformed was pulmonary vein isolation (PVI) ) +/- cavo-tricuspid isthmus (CTI) line. Ablation techniques employed in previous AFA can be radiofrequency ablation (RFA), pulsed-field ablation (PFA) or cyoballoon ablation (CBA).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Persistent AF > 3 years
• Patient with previous AFA which involved non-pulmonary vein (PV) targets such as left atrial posterior wall isolation, mitral isthmus line, superior vena cava (SVC) isolation, atypical atrial flutter lines)
• Pregnant or breastfeeding females.
• Inability to provide informed consent.
• Medical comorbidity where anticoagulation is contra-indicated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
25/11/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 317542 0
Hospital
Name [1] 317542 0
John Hunter Hospital staff time/resources/facilities
Country [1] 317542 0
Australia
Primary sponsor type
Individual
Name
Michael Malaty - John Hunter Hospital
Address
Country
Australia
Secondary sponsor category [1] 319848 0
None
Name [1] 319848 0
Address [1] 319848 0
Country [1] 319848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316254 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316254 0
Ethics committee country [1] 316254 0
Australia
Date submitted for ethics approval [1] 316254 0
13/07/2024
Approval date [1] 316254 0
28/08/2024
Ethics approval number [1] 316254 0

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

Contacts
Principal investigator
Name 137298 0
Dr Michael Malaty
Address 137298 0
John Hunter Hospital, 1 Lookout Rd, New Lambton Heights NSW 2305
Country 137298 0
Australia
Phone 137298 0
+61433017018
Fax 137298 0
Email 137298 0
[email protected]
Contact person for public queries
Name 137299 0
Michael Malaty
Address 137299 0
John Hunter Hospital, 1 Lookout Rd, New Lambton Heights NSW 2305
Country 137299 0
Australia
Phone 137299 0
+61 02 4921 3000
Fax 137299 0
Email 137299 0
[email protected]
Contact person for scientific queries
Name 137300 0
Michael Malaty
Address 137300 0
John Hunter Hospital, 1 Lookout Rd, New Lambton Heights NSW 2305
Country 137300 0
Australia
Phone 137300 0
+61 02 4921 3000
Fax 137300 0
Email 137300 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24239Ethical approval    388560-(Uploaded-02-10-2024-23-44-57)-2024_ETH01566_ Application HREA - Approved.rtf



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.