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
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the Cathrx ablation catheter for right atrial flutter ablation
Scientific title
A study to evaluate the effects of the CathRx ablation catheter on be-directional block of the cavo-tricuspid isthmus for right atrial flutter.
Secondary ID [1] 283477 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Right Atrial Flutter 4215 0
Condition category
Condition code
Cardiovascular 4568 4568 0 0
Other cardiovascular diseases
Cardiovascular 4613 4613 0 0
Coronary heart disease

Study type
Description of intervention(s) / exposure
The CathRx ablation catheter is a new irrigated ablation catheter that will be assessed in this study. It will utilise the same radio frequency( RF)generator and irrigation pump as a conventional catheter. The main benefit of the CathRx catheter is that it has a hollow lumen which permits the insertion of a range of stylets with different curves facilitating appropriate shape formation of the distal end of the catheter. This allows accurate positioning for delivery of therapy.The Cathrx ablation catheter is inserted via the femoral vein. Only one ablation catheter will be used during the procedure. The duration of th procedure is up to the clinicial procedures usually take an average of three hours
Intervention code [1] 3931 0
Treatment: Devices
Comparator / control treatment
not applicable as this is a single group study
Control group

Primary outcome [1] 5313 0
To assess the effects of the CathRx irrigated ablation catheter on bidirectional block of the cavo- tricuspid isthmus this is measured by the participant no longer having Atrial Flutter. As assessed by electrocardiogram.
Timepoint [1] 5313 0
Acute success of procedure is measured.Immediately after the completion of the procedure.
Secondary outcome [1] 8937 0
The clinician's assessment of procedure time
Timepoint [1] 8937 0
This is measured at the time of the procedure.

Key inclusion criteria
All subjects assessed by standard clinical practice, who require ablation for typical right atrial flutter will be eligible for the proposed study
Minimum age
18 Years
Maximum age
100 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
subjects who are pregnant,
under going repeat atrial flutter (AFL)ablation procedure,
under 18 years of age,
In emergency/intensive care,
with impaired mental capacity

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
15 consecutive subjects undergoing cavo-tricuspid isthmus (CTI ) ablation for right atrial flutter will be recruited by their treating physician. The population ti be studied are subjects who have been routinely referred for a cardiac ablation procedure.
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4503 0
Commercial sector/Industry
Name [1] 4503 0
CathRx Ltd
Address [1] 4503 0
5 Parkview Dr.
Homebush Bay NSW 2127
Country [1] 4503 0
Primary sponsor type
Commercial sector/Industry
CathRx Ltd
5 Parkview Drive
Homebush Bay NSW 2127
Secondary sponsor category [1] 4062 0
Name [1] 4062 0
Address [1] 4062 0
Country [1] 4062 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6559 0
Southern Health Human Ethics Committee
Ethics committee address [1] 6559 0
Ethics committee country [1] 6559 0
Date submitted for ethics approval [1] 6559 0
Approval date [1] 6559 0
Ethics approval number [1] 6559 0

Brief summary
This research project is assessing a new burning catheter, the modular ablation catheter, this catheter will burn the irregular electrical connection that causes an irregular cardiac arrthymia. The catheter is being assessed to ensure that is not inferior to a conventional catheter. The trial catheter has benefits for the clinician in that it can be more adaptable during the clinical procedure than standard catheters and hence it is not inferior to current technology it should provide an attractive catheter choice for the clincian.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35102 0
Dr David Adams
Address 35102 0
Level 2 (street level)
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 35102 0
Phone 35102 0
Fax 35102 0
61 3 9594 6012
Email 35102 0
Contact person for public queries
Name 12449 0
Mr roman greifeneder
Address 12449 0
5 Parkview Drive homebush Bay NSW 2127
Country 12449 0
Phone 12449 0
Fax 12449 0
61 2 9397 5701
Email 12449 0
Contact person for scientific queries
Name 3377 0
Dr Dr Ross Matthews
Address 3377 0
5 Parkview Drive
Homebush Bay NSW 2127
Country 3377 0
Phone 3377 0
61 2 9397 5731
Fax 3377 0
61 2 9397 5701
Email 3377 0

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