Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000310268
Ethics application status
Not yet submitted
Date submitted
16/02/2009
Date registered
19/05/2009
Date last updated
12/11/2018
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
NIL
Universal Trial Number (UTN)
nil
Trial acronym
nil
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

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4503 0
Commercial sector/Industry
Name [1] 4503 0
CathRx Ltd
Country [1] 4503 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
CathRx Ltd
Address
5 Parkview Drive
Homebush Bay NSW 2127
Country
Australia
Secondary sponsor category [1] 4062 0
None
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
Australia
Date submitted for ethics approval [1] 6559 0
18/12/2008
Approval date [1] 6559 0
Ethics approval number [1] 6559 0

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

Contacts
Principal investigator
Name 35102 0
Dr David Adams
Address 35102 0
MonashHeart
Level 2 (street level)
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 35102 0
Australia
Phone 35102 0
1300MHEART
Fax 35102 0
61 3 9594 6012
Email 35102 0
Maryanne.Austin@southernhealth.org.au
Contact person for public queries
Name 12449 0
roman greifeneder
Address 12449 0
5 Parkview Drive homebush Bay NSW 2127
Country 12449 0
Australia
Phone 12449 0
61293975730
Fax 12449 0
61 2 9397 5701
Email 12449 0
roman.greifeneder@cathrx.com
Contact person for scientific queries
Name 3377 0
Dr Ross Matthews
Address 3377 0
5 Parkview Drive
Homebush Bay NSW 2127
Country 3377 0
Australia
Phone 3377 0
61 2 9397 5731
Fax 3377 0
61 2 9397 5701
Email 3377 0
ross.matthews@cathrx.com

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.