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Trial registered on ANZCTR


Registration number
ACTRN12621000003875p
Ethics application status
Submitted, not yet approved
Date submitted
20/10/2020
Date registered
7/01/2021
Date last updated
7/01/2021
Date data sharing statement initially provided
7/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
POLARx™ versus Arctic Front Advance™ Cryoablation Systems for Patients with Atrial Fibrillation.
Scientific title
A Dual-Centre Randomised Double-Blind Trial comparing the Arctic Front Advance™ Cryoballoon to the POLARx™ Cryoablation System for Pulmonary Vein Isolation in patients with Atrial Fibrillation.
Secondary ID [1] 302242 0
Nil known
Universal Trial Number (UTN)
U1111-1258-0375
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 318958 0
Condition category
Condition code
Cardiovascular 316929 316929 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cryoablation for atrial fibrillation with the POLARx™ Cryoablation System. Pulmonary vein isolation (PVI) will occur once during the trial following randomisation. PVI will take approximately 1.5-2 hours. This will be performed by a cardiac electrophysiologist.
Intervention code [1] 318531 0
Treatment: Devices
Comparator / control treatment
Cryoablation for atrial fibrillation with the Arctic Front Advance™ Cryoballoon. Pulmonary vein isolation (PVI) will occur once during the trial following randomisation. PVI will take approximately 1.5-2 hours. This will be performed by a cardiac electrophysiologist.
Control group
Active

Outcomes
Primary outcome [1] 325034 0
Total Procedure Time - recorded at the time of ablation from patient notes
Timepoint [1] 325034 0
At time of cryoablation
Primary outcome [2] 326076 0
Total Ablation Time - recorded at the time of ablation from patient notes
Timepoint [2] 326076 0
At time of cryoablation
Secondary outcome [1] 386608 0
Complications of pulmonary vein isolation assessed just after ablation and at 3, 6, 9 and 12 months following the procedure. These complications include:
o Groin site complication
o Transient phrenic nerve palsy
o Persistent phrenic nerve palsy
o Cardiac Tamponade
o Atrio-oesophageal fistula
o Pulmonary vein stenosis
o Ischaemic Stroke
o Death from any cause
These will be assessed via
1. Documentation from the procedure
2. Patient questioning at follow-up
3. Review of medical records within the health network
Timepoint [1] 386608 0
12 months post-ablation
Secondary outcome [2] 386609 0
Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure). This will be assessed through a combination of patient medical records and clinical follow-up at 3, 6, 9 and 12 months after ablation.
Timepoint [2] 386609 0
3 months post-ablation
6 months post-ablation
9 months post-ablation
12 months post ablation
Secondary outcome [3] 386610 0
Burden of recurrent symptomatic documented AF episodes assessed on follow-up visits at 3, 6, 9 and 12 months and based on outpatient holter monitors.

Timepoint [3] 386610 0
3 months post-ablation
6 months post-ablation
9 months post-ablation
12 months post ablation
Secondary outcome [4] 389072 0
Burden of recurrent documented AF episodes assessed on follow-up visits at 3, 6, 9 and 12 months and based on outpatient holter monitors.
Timepoint [4] 389072 0
3 months post-ablation
6 months post-ablation
9 months post-ablation
12 months post ablation
Secondary outcome [5] 389073 0
Time to recurrence of AF assessed on follow-up visits at 3, 6, 9 and 12 months and based on outpatient holter monitors.
Timepoint [5] 389073 0
3 months post-ablation
6 months post-ablation
9 months post-ablation
12 months post ablation
Secondary outcome [6] 389074 0
Any symptomatic AF recurrence assessed on follow-up visits at 3, 6, 9 and 12 months.
1. Patient medical records
2. Patient questioning by the clinician at follow-up
Timepoint [6] 389074 0
3 months post-ablation
6 months post-ablation
9 months post-ablation
12 months post ablation
Secondary outcome [7] 389075 0
Hospitalisation as assessed on follow-up visits at 3, 6, 9 and 12 months.
This will be assessed via
1. Patient medical records
2. Patient questioning by the clinician at follow-up
Timepoint [7] 389075 0
3 months post-ablation
6 months post-ablation
9 months post-ablation
12 months post ablation

Eligibility
Key inclusion criteria
• Age between 17-80 years.
• Have permanent or paroxysmal AF.
• Are referred for AF ablation after failure of at least one antiarrhythmic drug (AAD).
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or breastfeeding females.
• Inability to provide informed consent.
• Severe left atrial (LA) dilatation (>6cm in diameter)
• 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)
Single-blinded trial with patients unaware of group assignments. Allocation via central randomisation by online randomisation software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17447 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 17448 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 31175 0
2305 - New Lambton
Recruitment postcode(s) [2] 31176 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 306665 0
Hospital
Name [1] 306665 0
Cardiology Department, John Hunter Hospital
Address [1] 306665 0
Lookout Rd, New Lambton Heights NSW 2305
Country [1] 306665 0
Australia
Funding source category [2] 306666 0
Hospital
Name [2] 306666 0
Monash Medical Centre, Melbourne
Address [2] 306666 0
246 Clayton Rd, Clayton VIC 3168
Country [2] 306666 0
Australia
Primary sponsor type
Individual
Name
Dr Nicholas Jackson
Address
Cardiology Department, John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 307215 0
Individual
Name [1] 307215 0
Dr Stuart Heally
Address [1] 307215 0
Monash Medical Centre
246 Clayton Rd, Clayton VIC 3168
Country [1] 307215 0
Australia
Other collaborator category [1] 281468 0
Individual
Name [1] 281468 0
David Ferreira
Address [1] 281468 0
Cardiology Department, John Hunter Hospital.
Lookout Rd, New Lambton Heights NSW 2305
Country [1] 281468 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306846 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 306846 0
Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 306846 0
Australia
Date submitted for ethics approval [1] 306846 0
12/11/2020
Approval date [1] 306846 0
Ethics approval number [1] 306846 0

Summary
Brief summary
This is a dual centre, randomised, double blinded trial of two pulmonary vein isolation systems for paroxysmal AF. Participants will be screened from all participants referred for pulmonary vein isolation aged between 17 and 80 years. Randomisation will occur after consent is obtained and on enrolment into the study. Participants will be randomised to pulmonary vein isolation with the Arctic Front Advance™ Cryoballoon or the POLARx™ Cryoablation System.

It is planned that 110 participants will be randomised in a 1:1 ratio to one of two treatment arms:
• 55 will undergo pulmonary vein isolation via the Arctic Front Advance™ Cryoballoon.
• 55 will undergo pulmonary vein isolation via the POLARx™ Cryoablation System.

Primary non-inferiority endpoints
• Total procedure time

Secondary safety and tolerability endpoints
• Complications of Pulmonary Vein Isolation.
• Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure).

Secondary efficacy endpoints:
• Burden of recurrent symptomatic documented AF episodes.
• Burden of recurrent documented AF episodes.
• Time to recurrence of AF.
• Any symptomatic AF recurrence.
• Hospitalisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105210 0
Dr Nicholas Jackson
Address 105210 0
Cardiology Department, John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country 105210 0
Australia
Phone 105210 0
+61 02 4921 4720
Fax 105210 0
Email 105210 0
Nicholas.Jackson@health.nsw.gov.au
Contact person for public queries
Name 105211 0
Dr Nicholas Jackson
Address 105211 0
Cardiology Department, John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country 105211 0
Australia
Phone 105211 0
+61 02 4921 4720
Fax 105211 0
Email 105211 0
Nicholas.Jackson@health.nsw.gov.au
Contact person for scientific queries
Name 105212 0
Dr Nicholas Jackson
Address 105212 0
Cardiology Department, John Hunter Hospital
Lookout Rd, New Lambton Heights NSW 2305
Country 105212 0
Australia
Phone 105212 0
+61 02 4921 4720
Fax 105212 0
Email 105212 0
Nicholas.Jackson@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data on baseline characteristics, group allocation and primary and secondary outcomes.
When will data be available (start and end dates)?
Ten years after completion of the trial (estimated 31/12/2023).
Available to whom?
Researchers from reputable institutions who provide reasonable proposals for data analysis.
Available for what types of analyses?
Analyses deemed reasonable and beneficial by the primary investigators. This may include individual patient meta analyses and literature reviews.
How or where can data be obtained?
By contacting the primary investigators.
Co-ordinating Primary Investigator: Dr Nicholas Jackson
Email: Nicholas.Jackson@health.nsw.gov.aU
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9491 0
Ethical approval
Citation [1] 9491 0
Link [1] 9491 0
Email [1] 9491 0
Nicholas.Jackson@health.nsw.gov.au
Other [1] 9491 0
Attachment [1] 9491 0
Type [2] 9492 0
Study protocol
Citation [2] 9492 0
Link [2] 9492 0
Email [2] 9492 0
Nicholas.Jackson@health.nsw.gov.au
Other [2] 9492 0
Attachment [2] 9492 0
Summary results
No Results