ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Cardiovascular

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]

Treatment: Devices

Intervention code [2]

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]

Total procedural X-ray time from the point at which venous access is gained until the removal of catheters.

Timepoint [1]

At the end of the clinical procedure

Secondary outcome [1]

3D navigational accuracy as assessed by 1) distance to the map surface and 2) distance from the pulmonary vein ostia.

Timepoint [1]

At the end of 3D map creation, before the beginning of the ablation procedure

Secondary outcome [2]

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]

3, 6, 9, 12 months after the procedure

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

21/01/2009

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]

Commercial sector/Industry

Name [1]

Biosense Webster, Johnson and Johnson

Address [1]

Johnson and Johnson Medical
1-5 Khartoum Road
North Ryde NSW 2113

Country [1]

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]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Prof. Prashanthan Sanders

Address [1]

Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital

Ethics committee address [1]

North Terrace
Adelaide
SA 5000
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/12/2007

Approval date [1]

30/01/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Prof. Prashanthan Sanders

Address

Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000

Country

Australia

Phone

+61 8 8222 2723

Fax

+61 8 8222 2722

prash.sanders@adelaide.edu.au

Contact person for scientific queries

Name

Dr. Anthony Brooks

Address

Centre for Heart Rhythm Disorders,
Level 5 McEwin Building
Royal Adelaide Hospital
North Terrace
Adelaide
SA. 5000

Country

Australia

Phone

+61 8 8313 1615

Fax

+61 8 8222 2722

anthony.brooks@adelaide.edu.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically