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Trial registered on ANZCTR


Registration number
ACTRN12610000800022
Ethics application status
Approved
Date submitted
20/09/2010
Date registered
27/09/2010
Date last updated
8/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of coronary sinus ablation for treatment of atrial fibrillation.
Scientific title
In long-episode/non-lone paroxysmal and persistent atrial fibrillation patients, is pulmonary vein isolation, roofline and coronary sinus ablation more effective than pulmonary vein isolation and roofline ablation in terms of drug free clinical success at 12 months?
Secondary ID [1] 252718 0
No secondary ID number
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug refractory non-lone/long episode paroxysmal or persistent atrial fibrillation 258211 0
Condition category
Condition code
Cardiovascular 258389 258389 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pulmonary vein isolation, roofline and coronary sinus ablation

Pulmonary vein isolation will be performed by positioning a circular mapping catheter sequentially at each pulmonary vein ostium, with location confirmed via fluoroscopy and virtual 3D navigation. Pulmonary vein isolation will be defined as abolition or dissociation of pulmonary vein potentials on a circumferential mapping catheter positioned at the ostium of the vein. All veins will be individually isolated via this technique. Common ostia venous architecture will be isolated en bloc with circumferential ablation and confirmation of electrical disconnection by positioning of the Lasso catheter within each of the inferior and superior branches. The permanence of electrical disconnection (ie. ablation line continuity) will be verified at least 30 minutes after the last ablation at that vein.

Roofline ablation will be performed in a continuous motion from the left superior pulmonary vein ostium to the right superior vein ostium as defined by fluoroscopy and 3D navigation. To maintain atrial wall contact, the ablation catheter will be looped within the atrium so that superior torque (ie. pressure on the roof) can be maintained throughout a continuous burn.

Ablation of the coronary sinus musculature and left atrium will be performed both endo- and epicardially through the coronary sinus in an attempt to electrically disconnect (ie. isolate) this structure from the left atrium. For the endocardial approach, the ablation catheter will be dragged along the endocardium of the inferior left atrium after looping the catheter in such a way as to position it parallel to the coronary sinus catheter. The ablation endpoint will be elimination of local endocardial electrograms bordering the mitral annulus. Ablation within the coronary sinus will be performed by starting distally (4 o’clock in the left anterior oblique position) and continuously dragged to the ostium, where the coronary sinus empties into the right atrium. Additional point ablation will be performed around the coronary sinus (CS) orifice from the right atrium to ensure its electrical disconnection from the atrial myocardium. The endpoint of epicardial ablation will be the electrical isolation (as represented by the abolition or dissociation of electrograms in the coronary sinus catheter) of the coronary sinus.

Total procedure duration should be 3-4 hours, inclusive of the time required to isolate the coronary sinus (30 mins).
Intervention code [1] 257225 0
Treatment: Surgery
Comparator / control treatment
Pulmonary vein isolation, roofline ablation

The control group does not undergo coronary sinus ablation and hence, patients randomized to this arm will have a procedure duration ranging between 2.5-3.5 hours.
Control group
Active

Outcomes
Primary outcome [1] 259231 0
Arrhythmia free clinical success (without anti-arrhythmic drugs) using a combination of patient symptoms and/or atrial fibrillation (AF) detected on 7 day Holter monitoring at 3 monthly intervals.
Timepoint [1] 259231 0
3, 6, 9, 12 months post procedure
Primary outcome [2] 259232 0
Peri-procedural and long term complications
eg.
Bleeding complications at catheter access site
Pericardial effusions detected via echocardiography
Pulmonary vein stenoses (via cardiac magnetic resonance imaging at 6 months)
Embolic events detected via symptoms and consequent clinical investigations (eg. computed tomography scan)
Timepoint [2] 259232 0
3, 6, 9, 12 months post procedure
Secondary outcome [1] 265636 0
Slowing of atrial fibrillation on a stable intracardiac catheter placed into the left atrial appendage after pulmonary vein isolation, roofline and coronary sinus ablation.

Termination to sinus rhythm at any stage of ablation via electrocardiography.
Timepoint [1] 265636 0
Slowing of atrial fribrillation will be assessed after each stage of ablation.

Termination to sinus rhythm will be monitored continously throughout the procedure

Eligibility
Key inclusion criteria
Drug refractory patients long-episode/non-lone paroxysmal and persistent atrial fibrillation presenting for a catheter ablation procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years,
Pregnancy,
Thrombus in left atrium on trans-esophageal echocardiogram,
Patients with lone paroxysmal AF (paroxysms lasting <48 hours) and permanent AF,
Patients unable to sustain induced AF for > 10 minutes

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)
Numbered sealed envelopes opened upon consent to the trial and confirmation of exclusion and inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomised with random block size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3288 0
5006 to 5116
Recruitment postcode(s) [2] 3289 0
5118
Recruitment postcode(s) [3] 3290 0
5125 to 5174
Recruitment postcode(s) [4] 3291 0
5240 to 5252
Recruitment postcode(s) [5] 3292 0
5000

Funding & Sponsors
Funding source category [1] 257674 0
Government body
Name [1] 257674 0
National Health and Medical Research Council
Country [1] 257674 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
5000
SA
Country
Australia
Secondary sponsor category [1] 256929 0
None
Name [1] 256929 0
Address [1] 256929 0
Country [1] 256929 0
Other collaborator category [1] 251503 0
Individual
Name [1] 251503 0
Dr. Anthony Brooks
Address [1] 251503 0
Level 5, McEwin Building
Royal Adelaide Hospital
North terrace
Adelaide
5000
S.A.
Country [1] 251503 0
Australia
Other collaborator category [2] 251504 0
Individual
Name [2] 251504 0
Dr. Glenn Young
Address [2] 251504 0
Level 5, McEwin Building
Royal Adelaide Hospital
North terrace
Adelaide
5000
S.A.
Country [2] 251504 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259700 0
Royal Adelaide Hospital (RAH) Ethics Committee
Ethics committee address [1] 259700 0
Ethics committee country [1] 259700 0
Australia
Date submitted for ethics approval [1] 259700 0
08/04/2008
Approval date [1] 259700 0
17/10/2008
Ethics approval number [1] 259700 0
080433

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

Contacts
Principal investigator
Name 31659 0
Address 31659 0
Country 31659 0
Phone 31659 0
Fax 31659 0
Email 31659 0
Contact person for public queries
Name 14906 0
Prof. Prashanthan Sanders
Address 14906 0
Level 5, McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide 5000
S.A.
Country 14906 0
Australia
Phone 14906 0
+61 8 8222 2725
Fax 14906 0
+61 8 8222 2722
Email 14906 0
[email protected]
Contact person for scientific queries
Name 5834 0
Dr. Anthony Brooks
Address 5834 0
Level 5, McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide 5000
S.A.
Country 5834 0
Australia
Phone 5834 0
+61 8 8313 1615
Fax 5834 0
+61 8 8222 2722
Email 5834 0
[email protected]

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