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Trial registered on ANZCTR


Registration number
ACTRN12612000089831
Ethics application status
Approved
Date submitted
17/01/2012
Date registered
18/01/2012
Date last updated
18/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Accuracy and clinical outcomes of CARTOSOUND compared to electro-anatomical mapping for atrial fibrillation ablation: A randomised controlled study.
Scientific title
In consecutive atrial fibrillation ablation patients, is CARTOSOUND guided atrial fibrillation ablation associated with reduced procedural X-ray exposure, superior navigational accuracy or greater effectiveness as compared to standard electro-anatomical mapping.
Secondary ID [1] 279748 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 atrial fibrillation 285606 0
Condition category
Condition code
Cardiovascular 285801 285801 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CARTO-SOUND 3D map development and guidance

An atrial fibrillation ablation procedure requires virtual 3D catheter guidance to increase procedure efficacy and decrease X-ray time compared to using fluoroscopic (ie. X-ray) guidance alone.

CARTOSOUND is a new mapping technology which allows a virtual navigational geometry to be created with an intra-cardiac ultra-sound catheter (ie SOUNDSTAR catheter) integrated into the standard 3D CARTOSOUND mapping platform.

The SOUNDSTAR catheter can be used to create the 3D map, which is used to guide and record ablation throughout the remaining procedure. Intra-cardiac ultrasound images from the SOUNDSTAR catheter can also be utilized to confirm catheter location in the heart, without X-ray verification.

This trial is relevant to a single AF ablation procedure with an approximate duration of 3.5 hours.
Intervention code [1] 284060 0
Treatment: Devices
Intervention code [2] 284065 0
Treatment: Surgery
Comparator / control treatment
Electro-anatomical mapping 3D map development and guidance


An atrial fibrillation ablation procedure requires virtual 3D catheter guidance to increase procedure efficacy and decrease X-ray time compared to using fluoroscopic (ie. X-ray) guidance alone.


Electro-anatomical mapping (EAM) is the current technology used to develop 3D navigational maps of the heart. EAM requires a catheter to be navigated to various locations in the heart, with assistance of fluoroscopy, to detail a point-by-point 3D shell of the heart chamber of interest.

Once created, this shell is used to guide and record ablation throughout the remaining case.

This trial is relevant to a single AF ablation procedure with an approximate duration of 3.5 hours.
Control group
Active

Outcomes
Primary outcome [1] 286311 0
Total procedural X-ray time from the point at which venous access is gained until the removal of catheters.
Timepoint [1] 286311 0
At the end of the clinical procedure
Secondary outcome [1] 295588 0
3D navigational accuracy as assessed by 1) distance to the map surface and 2) distance from the pulmonary vein ostia.
Timepoint [1] 295588 0
At the end of 3D map creation, before the beginning of the ablation procedure
Secondary outcome [2] 295589 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 [2] 295589 0
3, 6, 9, 12 months after the procedure
Secondary outcome [3] 295590 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 [3] 295590 0
3, 6, 9, 12 months after the procedure

Eligibility
Key inclusion criteria
Drug refractory atrial fibrillation ablation patients presenting for an atrial fibrillation ablation procedure
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years,
Pregnancy,
Thrombus in left atrium on trans-esophageal echocardiogram,

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 randomised - equal numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 284530 0
Commercial sector/Industry
Name [1] 284530 0
Biosense Webster, Johnson and Johnson
Address [1] 284530 0
Johnson and Johnson Medical
1-5 Khartoum Road
North Ryde NSW 2113
Country [1] 284530 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
The University of Adelaide
North Terrace
SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 283459 0
Hospital
Name [1] 283459 0
Royal Adelaide Hospital
Address [1] 283459 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 283459 0
Australia
Other collaborator category [1] 260458 0
Individual
Name [1] 260458 0
Prof. Prashanthan Sanders
Address [1] 260458 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 260458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286515 0
Royal Adelaide Hospital
Ethics committee address [1] 286515 0
North Terrace
Adelaide
SA 5000
Australia
Ethics committee country [1] 286515 0
Australia
Date submitted for ethics approval [1] 286515 0
21/12/2007
Approval date [1] 286515 0
30/01/2008
Ethics approval number [1] 286515 0
071217

Summary
Brief summary
In the last decade, catheter ablation procedures for atrial fibrillation (AF) have increased dramatically and this therapy is now a well entrenched treatment option for drug-refractory AF. The technology associated with mapping the atrial anatomy and localization of catheters within the heart has concurrently evolved to meet the demands of pulmonary vein isolation procedures for paroxysmal AF and a variety of adjunctive substrate ablation approaches for non-paroxysmal AF.

Navigation technologies aim to improve clinical outcome, increase safety, reduce procedure times and reduce X-ray exposure for AF ablation procedures. Compared to fluoroscopy led ablation, early randomized trials reported shorter procedure times and reduced X-ray for adjunctive virtual 3D mapping. Non-randomized trials/registries have suggested that adding CT/MRI merge capabilities to 3D mapping provides incremental benefit over 3D mapping alone; however, randomized trials have proven that the addition of CT/MRI merge capabilities to 3D mapping systems may be associated with negligible impact on clinical results and/or X-ray use. Furthermore, randomized evidence for new radiographic mapping technologies (3D rotational angiography) and early data on robotic sheath navigation also result in equivalence compared to standard 3D guided procedures.

Prior studies have demonstrated the efficacy of intracardiac echocardiography (ICE) for guiding ablation at the pulmonary vein ostia, within the cavotricuspid isthmus and for detection of left atrial thrombus and assessment of left atrial appendage mechanical function. In addition, one recent case series has reported ‘flouro-less’ AF ablation procedures with ICE as an adjunct to 3D mapping.
CARTOSOUND integrates ICE into a 3D mapping system, such that the CARTO system can visualize the location and orientation of a specialized ICE catheter to enable the construction of a 3D geometry from a series of 2D ultrasound slices. CARTOSOUND has been validated in an animal model, tested in several clinical patient series and its unique utility is described in case reports. However, there have been no studies that have assessed the impact of CARTOSOUND mapping/navigation on AF ablation outcomes as compared to conventional EAM.

We sought to compare clinical parameters and mapping accuracy between CARTOSOUND and EAM mapping/navigation for AF ablation procedures via a randomized controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33646 0
Address 33646 0
Country 33646 0
Phone 33646 0
Fax 33646 0
Email 33646 0
Contact person for public queries
Name 16893 0
Prof. Prashanthan Sanders
Address 16893 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000
Country 16893 0
Australia
Phone 16893 0
+61 8 8222 2723
Fax 16893 0
+61 8 8222 2722
Email 16893 0
prash.sanders@adelaide.edu.au
Contact person for scientific queries
Name 7821 0
Dr. Anthony Brooks
Address 7821 0
Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000
Country 7821 0
Australia
Phone 7821 0
+61 8 8313 1615
Fax 7821 0
+61 8 8222 2722
Email 7821 0
anthony.brooks@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary