Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000509167
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
29/03/2019
Date last updated
18/06/2021
Date data sharing statement initially provided
29/03/2019
Date results information initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of Safety and Performance of the Radio Frequency Catheter System to Isolate Pulmonary Veins in the Treatment of Paroxysmal Atrial Fibrillation Control Study
Scientific title
Assessment of Safety and Performance of the Radio Frequency Catheter System to Isolate Pulmonary Veins in the Treatment of Paroxysmal Atrial Fibrillation Control Study
Secondary ID [1] 297548 0
None
Universal Trial Number (UTN)
Trial acronym
AF-FICIENT Control
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 311772 0
Condition category
Condition code
Cardiovascular 310384 310384 0 0
Other cardiovascular diseases
Surgery 310620 310620 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiofrequency (RF) ablation. Procedural times can vary from one hour to approximately three hours depending upon the ability to isolate veins using radiofrequency and to restore rhythm to normal sinus. Subjects will also undergo a brain MRI before and after the ablation procedure.
Radiofrequency ablation should be used within the device directions for use (generally a range of in the range of 350–500 kHz).
Intervention code [1] 313779 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319263 0
The goal of the study is to collect brain MRI data specific to asymptomatic cerebral events (ACE) for commercially available RF catheters in patients indicated for ablation treatment for de-novo paroxysmal atrial fibrillation (PAF).

No formal endpoints or hypothesis testing are planned in the study.
Timepoint [1] 319263 0
Within 7 days post-procedure
Secondary outcome [1] 367491 0
None
Timepoint [1] 367491 0
None

Eligibility
Key inclusion criteria
History of symptomatic, documented paroxysmal atrial fibrillation
Suitable candidate for catheter non-emergent intra-cardiac mapping and ablation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Structural heart disease of clinical significance including previous cardiac surgery (excluding CABG or mitral valve repair)
Documented EF <30%
Left atrial diameter of >55mm
Contraindication to anticoagulation therapy
Unstable angina or ongoing myocardial ischemia
Myocardial infarction within 3 months of enrollment
Congenital heart disease where the underlying abnormality increases the risk of the ablation
Prior Atrial Septal Defect or Patent Foramen Ovale Closure with a device using a transcatheter percutaneous approach
Hypertrophic cardiomyopathy (LV septal wall thickness >1.5cm)
Pulmonary hypertension (>50mm Hg)
Prior ablation for atrial fibrillation
Enrollment in any other ongoing arrhythmia study protocol
Patients with severely impaired kidney function as measured by Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29
Active gastrointestinal bleeding, infection or fever (>100.5/38C) or sepsis
Short life expectancy (<1 year) due to illness such as cancer, pulmonary,hepatic or renal disease
Significant anemia (hemoglobin < 8.0 / dl)
Severe uncontrolled systemic hypertension with systolic >200mm Hg within ast 30 days
Documented anaphylaxis during previous exposure to contrast media
Bleeding or clotting disorders or thrombotic disorder under treatment
Uncontrolled diabetes
Women who are pregnant and not willing to use contraception for the duration of the study
Severe COPD (identified by an FEV1 <1)
Unwilling or unable to comply with any protocol or follow up requirements

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
31/05/2019
Actual
22/07/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
4/03/2020
Date of last data collection
Anticipated
30/06/2020
Actual
30/03/2020
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 21318 0
New Zealand
State/province [1] 21318 0
Christchurch

Funding & Sponsors
Funding source category [1] 302103 0
Commercial sector/Industry
Name [1] 302103 0
Boston Scientific
Country [1] 302103 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific
Address
Boston Scientific
4100 Hamline Ave.
Arden Hills, MN 55127
Country
United States of America
Secondary sponsor category [1] 301931 0
None
Name [1] 301931 0
Address [1] 301931 0
Country [1] 301931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302781 0
Central: Health and Disability Ethics Committees
Ethics committee address [1] 302781 0
The address is: Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011

Ethics committee country [1] 302781 0
New Zealand
Date submitted for ethics approval [1] 302781 0
07/03/2019
Approval date [1] 302781 0
31/03/2019
Ethics approval number [1] 302781 0

Summary
Brief summary
The AF-FICIENT Control study is a prospective, non-randomized, single center, single arm study. The objective of the study is to collect brain MRI data specific to asymptomatic cerebral events (ACE) for commercially available RF catheters in patients indicated for ablation treatment for de-novo paroxysmal atrial fibrillation (PAF).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91382 0
Prof Ian Crozier
Address 91382 0
Christchurch Hospital
2 Riccarton Avenue
PO Bag 4710
Christchurch 8140
Country 91382 0
New Zealand
Phone 91382 0
+64 3640640
Fax 91382 0
Email 91382 0
[email protected]
Contact person for public queries
Name 91383 0
Mrs Allison Anderson
Address 91383 0
Boston Scientific
4100 Hamline Ave
Arden Hills, MN 55110
Country 91383 0
United States of America
Phone 91383 0
+1 651-582-5077
Fax 91383 0
Email 91383 0
[email protected]
Contact person for scientific queries
Name 91384 0
Mrs Allison Anderson
Address 91384 0

Boston Scientific
4100 Hamline Ave
Arden Hills, MN 55110
Country 91384 0
United States of America
Phone 91384 0
+1 651-582-5077
Fax 91384 0
Email 91384 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo There were no specified safety or effectiveness en... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe AF-FICIENT magnetic resonance imaging and endoscopy safety substudy: A visually guided radiofrequency balloon ablation catheter for pulmonary vein isolation2021https://doi.org/10.1016/j.hroo.2021.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.