Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000763448
Ethics application status
Approved
Date submitted
3/06/2016
Date registered
9/06/2016
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Date results information initially provided
19/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety Study of the .AlCath Force catheter in patients with atrial arrhythmias
Scientific title
Safety of the AlCath Force catheter during radiofrequency ablation in patients with atrial fibrillation or atrial flutter
Secondary ID [1] 289360 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial tachyarrhythmia 298993 0
Condition category
Condition code
Cardiovascular 299057 299057 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Catheter ablation is an atrial fibrillation treatment that is done by a specialized cardiologist, called an electrophysiologist (EP), who deals with irregular heartbeats (arrhythmias).
It is a minimally-invasive procedure that is generally less invasive than surgery. It is a commonly-used treatment for atrial fibrillation as well as other cardiac arrhythmias.
It is done on a beating heart in a closed chest procedure. Small punctures are made in the groin and the catheters, are inserted and threaded to the heart. Once there, the catheter's tip is threaded through a tiny incision in the wall between the left and right atria (septal wall), and is positioned to ablate tissue around the pulmonary veins or at other sources of erratic electrical signals that cause the irregular heartbeat. In case of atrial flutter, the catheter is used in the right atrium to electrically isolate the cavotricuspid isthmus which is a known pathway for atrial flutter waves.
The catheter uses an energy source, such as radio frequency energy (radio waves) to create a lesion of scar tissue, called a conduction block, that stops the erratic electrical signals from travelling through the heart.
The procedure usually takes around 2 to 4 hours per patient.
The AlCath Force catheter which is used in this study is an irrigated radio frequency ablation catheter with contact force (CF) sensing capability. The catheter is connected to the Qubic Force device which derives the CF information from the signal received from the catheter.
Intervention code [1] 294945 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298530 0
Acute procedural success rate, i.e. ability to terminate cardiac arrhythmia as evidenced by restoration of normal sinus rhythm on the ECG and relief of patient's symptoms by use of the study device only
Timepoint [1] 298530 0
At end of procedure
Secondary outcome [1] 324482 0
Serious Adverse Device Effects free rate per catheter (Known serious adverse events during catheter ablation are cardiac tamponade, pericardial effusion, induction of arrhythmias both by induced voltages as well as physical catheter manipulation, thromboembolism, pulmonary vein stenosis etc.). The adverse events will be assessed by ECG during the procedure as well as review of medical records .
Timepoint [1] 324482 0
Pre-hospital discharge
Secondary outcome [2] 324483 0
Serious Adverse Device Effects free rate per patient (Known serious adverse events during catheter ablation are cardiac tamponade, pericardial effusion, induction of arrhythmias both by induced voltages as well as physical catheter manipulation, thromboembolism, pulmonary vein stenosis etc.). The adverse events will be assessed by ECG during the procedure as well as review of medical records .
Timepoint [2] 324483 0
Pre-hospital discharge
Secondary outcome [3] 324484 0
Rate of devices with one or more deficiencies by review of procedure records (device deficiency as defined by ISO14155)
Timepoint [3] 324484 0
At end of procedure

Eligibility
Key inclusion criteria
Paroxysmal AF with indication and consideration for pulmonary vein isolation (PVI) and/or atrial flutter with indication and consideration for cavotricuspid isthmus ablation
legal capacity and ability to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contraindications for ablation therapy
Plan to combine the study procedure with any other cardiac intervention
Previous atrial ablation
Prior ischemic stroke or transient ischemic attack
Pregnancy or breast feeding
Participation in another interventional clinical investigation

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/06/2016
Actual
1/07/2016
Date of last participant enrolment
Anticipated
22/07/2016
Actual
29/07/2016
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 293744 0
Commercial sector/Industry
Name [1] 293744 0
BIOTRONIK Australia Pty. Ltd.
Country [1] 293744 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BIOTRONIK Australia Pty. Ltd.
Address
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 292573 0
None
Name [1] 292573 0
Address [1] 292573 0
Country [1] 292573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295180 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 295180 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 295180 0
Australia
Date submitted for ethics approval [1] 295180 0
11/11/2015
Approval date [1] 295180 0
26/05/2016
Ethics approval number [1] 295180 0
HREC/15/QPAH/740

Summary
Brief summary
The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the AlCath Force ablation catheter and the Qubic Force device. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66402 0
Dr Stewart Healy
Address 66402 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 66402 0
Australia
Phone 66402 0
+61 1300 643 278
Fax 66402 0
Email 66402 0
[email protected]
Contact person for public queries
Name 66403 0
Dr Stewart Healy
Address 66403 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 66403 0
Australia
Phone 66403 0
+61 1300 643 278
Fax 66403 0
Email 66403 0
[email protected]
Contact person for scientific queries
Name 66404 0
Dr Stewart Healy
Address 66404 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 66404 0
Australia
Phone 66404 0
+61 1300 643 278
Fax 66404 0
Email 66404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is commercial in confidence


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
Update to Study Results
Documents added automatically
No additional documents have been identified.