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Trial registered on ANZCTR


Registration number
ACTRN12610000863033
Ethics application status
Approved
Date submitted
23/03/2010
Date registered
14/10/2010
Date last updated
14/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Curing Atrial Fibrillation: A Comparison of 2 Keyhole Techniques
Scientific title
Minimal versus Maximal Radiofrequency Ablation to Achieve Enduring freedom from Atrial Fibrillation
Secondary ID [1] 1596 0
None
Universal Trial Number (UTN)
U1111-1114-5079
Trial acronym
MINIMAX Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 257016 0
Condition category
Condition code
Cardiovascular 257177 257177 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulmonary vein isolation by wide encircling ablation of ipsilateral veins with linear ablation of the intervenous ridge. This procedure takes 2-4 hours and involves advancing specialized catheters into the heart via a keyhole approach, and using heat energy to place strategically-positioned scars in the upper chambers of the heart to cure atrial fibrillation. It is done as a one-off procedure, though occassionally a second procedure is required.
Intervention code [1] 256195 0
Treatment: Other
Comparator / control treatment
Pulmonary vein isolation by wide encircling ablation of ipsilateral veins without linear ablation of the intervenous ridge. This procedure takes 2-4 hours and involves advancing specialized catheters into the heart via a keyhole approach, and using heat energy to place strategically-positioned scars in the upper chambers of the heart to cure atrial fibrillation. It is done as a one-off procedure, though occassionally a second procedure is required.
Control group
Active

Outcomes
Primary outcome [1] 258074 0
Single procedure success at 12 months from the date of procedure defined by freedom from atrial fibrillation by symptoms and holter monitoring.
Timepoint [1] 258074 0
12 months from the date of procedure.
Secondary outcome [1] 263647 0
Procedural complications at 12 months from the date of procedure. Acute complications: pericaridal tamponade judged by need for pericardiocentesis, signficant groin haematoma/bleed judged by need for ultrasound imaging or blood transfusion, stroke based on clinical assessment post procedure and at follow up. Long-term complications: pulmonary vein stenosis based on follow-up CT pulmonary venography.
Timepoint [1] 263647 0
12 months from the date of procedure.

Eligibility
Key inclusion criteria
Age 18 or greater
Paroxysmal atrial fibrillation
Failure of at least one antiarrhythmic medication
Suitable for 1st time atrial fibrillation ablation
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Contraindications to atrial fibrillation 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)
Patients referred for consideration of first time atrial fibrillation (AF) ablation will be screened and enrolled. Randomization into interventional arms will be determined by coin-toss on the day of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by coin-tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Multicentre
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)
Recruitment outside Australia
Country [1] 2555 0
United Kingdom
State/province [1] 2555 0
Cambridge

Funding & Sponsors
Funding source category [1] 256694 0
Other Collaborative groups
Name [1] 256694 0
Clinical Electrophysiology Research, Baker IDI Heart and Diabetes Institute
Address [1] 256694 0
75 Commercial Road
Melbourne
Victoria 2004
Country [1] 256694 0
Australia
Primary sponsor type
Other Collaborative groups
Name
A/Prof Peter Kistler
Address
Clinical Electrophysiolog Research, Baker IDI Heart and Diabetes Institute
75 Commercial Road
Melbourne
Victoria 2004
Country
Australia
Secondary sponsor category [1] 255979 0
Hospital
Name [1] 255979 0
Alfred Hospital
Address [1] 255979 0
Commercial Road
Prahran
Victoria 3181
Country [1] 255979 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258712 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 258712 0
Commercial Road
Prahran
Victoria 3181
Ethics committee country [1] 258712 0
Australia
Date submitted for ethics approval [1] 258712 0
24/02/2010
Approval date [1] 258712 0
11/03/2010
Ethics approval number [1] 258712 0
31/10/2010

Summary
Brief summary
Atrial fibrillation is a common heart rhythm disorder and is associated with heart rhythm irregularity. This trial aims to compare the relative efficacy of 2 different keyhole procedures to cure atrial fibrillation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30972 0
Address 30972 0
Country 30972 0
Phone 30972 0
Fax 30972 0
Email 30972 0
Contact person for public queries
Name 14219 0
Liang-han Ling
Address 14219 0
Clinical Electrophysiology Research
Baker IDI Heart and Diabetes Institute
75 Commerical Road
Melbourne
Victoria 3004
Country 14219 0
Australia
Phone 14219 0
+61385321111
Fax 14219 0
+61385321100
Email 14219 0
han.ling@bakeridi.edu.au
Contact person for scientific queries
Name 5147 0
Liang-han Ling
Address 5147 0
Clinical Electrophysiology Research
Baker IDI Heart and Diabetes Institute
75 Commerical Road
Melbourne
Victoria 3004
Country 5147 0
Australia
Phone 5147 0
+61385321111
Fax 5147 0
+61385321100
Email 5147 0
han.ling@bakeridi.edu.au

No information has been provided regarding IPD availability
Summary results
No Results