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Trial registered on ANZCTR


Registration number
ACTRN12615000967583
Ethics application status
Approved
Date submitted
26/08/2015
Date registered
16/09/2015
Date last updated
22/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Cryoballoon ablation compared with single ring radiofrequency ablation for the treatment of atrial fibrillation: The Hot and Cold Study
Scientific title
In patients with paroxysmal atrial fibrillation not controlled on medical therapy, does single ring pulmonary vein isolation, compared with cryoballoon ablation, lead to reductions in recurrence of atrial tachyarrythmias.
Secondary ID [1] 287221 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paroxysmal atrial fibrillation 295824 0
Condition category
Condition code
Cardiovascular 296082 296082 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cryoablation will be performed using the Arctic Front device (Medtronic, St Paul, MN, USA) and Enquiry mapping catheter. This device is inflated within each vein orifice. The current recommended approach is to perform two 4 minute inflations within each pulmonary vein with additional freezes if electrical isolation has not been achieved. A 28mm balloon will be used where possible. The procedural end point will be durable (>30minutes) electrical isolation of all pulmonary veins.
Intervention code [1] 292510 0
Treatment: Other
Intervention code [2] 292801 0
Treatment: Devices
Intervention code [3] 292802 0
Treatment: Surgery
Comparator / control treatment
Percutaneous catheter ablation will be performed using irrigated radiofrequency catheters and guided by an electroanatomical mapping system. The single ring technique will be used to isolate all four veins and the posterior left atrium. This creates a wider isolation compared to that produced by the cryoablation balloon. The procedural end point will be durable (>30minutes) electrical isolation of the entire posterior wall including the pulmonary veins.


Control group
Active

Outcomes
Primary outcome [1] 295756 0
Arrhythmia free survival as a composite of freedom from atrial fibrillation, atrial flutter or need for ongoing antiarrhythmic therapy for atrial tachyarrhythmias more than 3 months post-procedure as assessed on routine Holter monitoring, symptomatic AF recurrence confirmed on ECG or otherwise ECG documented AF recurrence.
Timepoint [1] 295756 0
12 months
Secondary outcome [1] 316420 0
Procedural duration from procedural records
Timepoint [1] 316420 0
At the conclusion of the procedure as assessed by the time taken to perform the procedure.
Secondary outcome [2] 316421 0
Radiation exposure during the procedure from procedural records.
Timepoint [2] 316421 0
At the conclusion of the procedure as assessed the fluroscopy dose during the procedure.
Secondary outcome [3] 316422 0
Documented atrial fibrillation post-procedure and before hospital discharge
Timepoint [3] 316422 0
At hospital discharge post-procedure assessed using medical records.
Secondary outcome [4] 316423 0
Procedural complications (including groin haematoma requiring cessation of anticoagulation, pericarditis with ECG changes, pneumonia, phrenic nerve injury with or without recovery, chest pain, oesophageal injury, pulmonary vein stenosis, embolic events including TIA, stroke, myocardial infarction or peripheral embolisation, cardiac tamponade and death) as assessed from procedural and medical records, clinical reviews at follow up.
Timepoint [4] 316423 0
12 months post procedure
Secondary outcome [5] 316424 0
Duration of hospital stay post-procedure from medical records
Timepoint [5] 316424 0
At discharge post-procedure
Secondary outcome [6] 316425 0
Procedure costs from hospital records
Timepoint [6] 316425 0
At discharge post-procedure
Secondary outcome [7] 316426 0
Atrial fibrillation recurrence within 3 months post-procedure as assessed on routine Holter monitoring, symptomatic AF recurrence confirmed on ECG or otherwise ECG documented AF recurrence.
Timepoint [7] 316426 0
3 months post-procedure
Secondary outcome [8] 316427 0
Atrial flutter within 3 months post-procedure as assessed on routine Holter monitoring, symptomatic AF recurrence confirmed on ECG or otherwise ECG documented AF recurrence.
Timepoint [8] 316427 0
3 months post-procedure
Secondary outcome [9] 316428 0
Atrial fibrillation recurrence between 3-12 months post-procedure as assessed on routine Holter monitoring, symptomatic AF recurrence confirmed on ECG or otherwise ECG documented AF recurrence.
Timepoint [9] 316428 0
12 months post-procedure
Secondary outcome [10] 316429 0
Atrial flutter recurrence between 3-12 months post-procedure as assessed on routine Holter monitoring, symptomatic AF recurrence confirmed on ECG or otherwise ECG documented AF recurrence.
Timepoint [10] 316429 0
12 months post-procedure
Secondary outcome [11] 316430 0
Quality of life measures as assessed on the validated SF-36 questionnaire and in terms of reported symptoms contained in medical records.
Timepoint [11] 316430 0
12 months post-procedure
Secondary outcome [12] 317362 0
Documented atrial flutter post-procedure and before hospital discharge
Timepoint [12] 317362 0
At hospital discharge post-procedure assessed using medical records.
Secondary outcome [13] 317363 0
Documented combine atrial fibrillation and flutter post-procedure and before hospital discharge
Timepoint [13] 317363 0
At hospital discharge post-procedure assessed using medical records.

Eligibility
Key inclusion criteria
Symptomatic paroxysmal atrial fibrillation with an indication for pulmonary vein isolation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 yrs of age.
Unable to provide informed consent.
Undergone previous left atrial surgical or ablation procedures for atrial fibrillation.
Contraindications to cryoballoon ablation or radiofrequency ablation.

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)
Informed consent will be obtained from eligible patients prior to enrolment into the trial. Allocation will be concealed by central randomisation using a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be performed with computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size required to have an 80% statistical power to resolve a 20% greater efficacy in achieving the primary outcome of arrhythmia free survival from atrial fibrillation with single ring isolation compared to cryoballoon ablation is 182 (91 in each arm). Assuming a loss to follow up rate of up to 15%, we therefore aim to recruit 220 patients.

The Kaplan-Meier method will be used to estimate the distribution of the primary endpoint for each group and the log-rank test used to compare the distributions between the treatment groups. Possible covariates will be evaluated using a proportional hazard model. The Chi-square test will be used to test the secondary outcomes. Descriptive measures and a repeated measures ANOVA will be performed on the QOL measures. Analysis will be performed on groups as originally assigned using an intention to treat analysis approach. Further analysis will be performed on an as treated basis.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/09/2015
Actual
27/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4136 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 291793 0
Hospital
Name [1] 291793 0
Cardiology Department, Westmead Hospital
Country [1] 291793 0
Australia
Primary sponsor type
Individual
Name
Stuart Thomas
Address
Department of Cardiology, Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 290454 0
Individual
Name [1] 290454 0
Pierre Qian
Address [1] 290454 0
Department of Cardiology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country [1] 290454 0
Australia
Other collaborator category [1] 278574 0
Individual
Name [1] 278574 0
Eddy Kizana
Address [1] 278574 0
Department of Cardiology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country [1] 278574 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293310 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 293310 0
Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Ethics committee country [1] 293310 0
Australia
Date submitted for ethics approval [1] 293310 0
Approval date [1] 293310 0
16/03/2015
Ethics approval number [1] 293310 0
4088

Summary
Brief summary
Atrial fibrillation (AF) is the most common heart rhythm disorder and develops in 20-25% of people over their lifetime. The initial treatment has been medication therapy, however in the past decade, a catheter ablation procedure called pulmonary vein isolation has become increasingly widely practiced and is more effective than medical therapy at treating AF. This is performed by introducing catheters via the groin veins to the heart. There are two methods available in Australia for performing this procedure which aims to electrically isolate the pulmonary veins from the rest of the left atrium to which they connect in the heart as these usually contain abnormal foci that trigger the initiation of AF. The first of the two methods utilises radiofrequency ablation to create burns to the inside of the left atrium to encircle the pulmonary veins and the back wall of the left atrium. From a recent randomised clinical trial, we have found that the use of a large single ring was better than the conventional two separate rings in preventing the recurrence of AF. The second method uses more recent technology and involves a cryoballoon catheter that freezes the tissues around the pulmonary veins to achieve the same effect. Recent studies of this technique has shown it to be a safe and effective means of performing pulmonary vein isolation. It is not known which of the two procedures is more effective. We aim in the present randomised controlled clinical trial to investigate the relative efficacy and safety of the two procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59338 0
A/Prof Stuart Thomas
Address 59338 0
Department of Cardiology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 59338 0
Australia
Phone 59338 0
+61298455458
Fax 59338 0
Email 59338 0
[email protected]
Contact person for public queries
Name 59339 0
Justine Thelander
Address 59339 0
Department of Cardiology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 59339 0
Australia
Phone 59339 0
+61298456795
Fax 59339 0
Email 59339 0
[email protected]
Contact person for scientific queries
Name 59340 0
Stuart Thomas
Address 59340 0
Department of Cardiology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rd
Westmead NSW 2145
Country 59340 0
Australia
Phone 59340 0
+61298455458
Fax 59340 0
Email 59340 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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