Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000313235
Ethics application status
Approved
Date submitted
4/02/2009
Date registered
21/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study to characterize electrograms in patients undergoing atrial fibrillation ablation
Scientific title
A Feasibility Pilot Study to Characterize Baseline Atrial Electrograms in Areas Targeted for Cather Ablation in Patients with Atrial Fibrillation Using the NavX System
Universal Trial Number (UTN)
Trial acronym
NavX PVI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 4267 0
Condition category
Condition code
Cardiovascular 4493 4493 0 0
Other cardiovascular diseases
Cardiovascular 4875 4875 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A map of fractionated potentials will be used during an atrial fibrillation (AF) ablation to define the area typically ablated during pulmonary vein antrum isolation using the Diagnostic Landmark Map. The procedure will take no more than 30 minutes.
Intervention code [1] 3993 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5375 0
Pulmonary vein atrum isolation: disappearance of all local potentials in the areas of the pulmonary vein antrum defined by early activation in sinus rhythm and during coronary sinus (CS) pacing and by the presence of fractionated potentials. This will be assessed using a circular mapping catheter.
Timepoint [1] 5375 0
baseline, 3 months, 6 months and 12 months post procedure.
Secondary outcome [1] 9038 0
Flouroscopy duration measured by the timer on the flouroscopy machine
Timepoint [1] 9038 0
at completion of procedure

Eligibility
Key inclusion criteria
-Any patient with atrial fibrillation requiring ablation
-able to achieve and maintain stable sinus rhythm during the mapping procedure
-be on therapeutic level of anticoagulation as determined by the physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with left atrial thrombus or heavy echo contrast on trans-esophageal echo (TEE) prior to the procedure as per physician discretion and standard of care
-Chronic atrial fibrillation
- Inadequate anticoagulation as defined in the inclusion criteria.
-Significant underlying pulmonary disease

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
Phase
Not Applicable
Type of endpoint/s
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
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1557 0
Canada
State/province [1] 1557 0
ON
Country [2] 1558 0
Canada
State/province [2] 1558 0

Funding & Sponsors
Funding source category [1] 4450 0
Commercial sector/Industry
Name [1] 4450 0
St Jude Medical
Country [1] 4450 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
St Jude Medical
Address
Unit 2- 6695 Millcreek Dr., Mississauga, ON, L5N 5R8
Country
Canada
Secondary sponsor category [1] 4009 0
None
Name [1] 4009 0
Address [1] 4009 0
Country [1] 4009 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6504 0
Southlake Region Health Center Research Ethics Board (REB)
Ethics committee address [1] 6504 0
Ethics committee country [1] 6504 0
Canada
Date submitted for ethics approval [1] 6504 0
Approval date [1] 6504 0
11/08/2008
Ethics approval number [1] 6504 0

Summary
Brief summary
This study will use a different ablation technique that involves creating a three dimensional map of the electrical activity of the heart, followed by identification and ablation of the areas of abnormal activity. It is hypothesized that this technique is feasible and effective and will achieve pulmonary vein antrum isolation, while lowering exposure to fluoroscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29247 0
Address 29247 0
Country 29247 0
Phone 29247 0
Fax 29247 0
Email 29247 0
Contact person for public queries
Name 12494 0
Linnea Aasen-Johnston
Address 12494 0
Unit 2- 6695 Millcreek Dr., Mississauga, ON, L5N 5R8
Country 12494 0
Canada
Phone 12494 0
+1 905-286-4009
Fax 12494 0
Email 12494 0
LAasen-Johnston@sjm.com
Contact person for scientific queries
Name 3422 0
Yaariv Khaykin
Address 3422 0
Southlake Region Health Center, 712 Davis Drive, Suite 105, Newmarket, Ontario, L3Y 8C3
Country 3422 0
Canada
Phone 3422 0
+1 905-895-4521
Fax 3422 0
Email 3422 0
y.khaykin@utoronto.ca

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
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