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Trial registered on ANZCTR


Registration number
ACTRN12615001340527
Ethics application status
Approved
Date submitted
2/10/2015
Date registered
8/12/2015
Date last updated
17/11/2021
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
17/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A First in Human Assessment of Safety and Performance of the Apama Radiofrequency (RF) Balloon Catheter System to Isolate Pulmonary Veins in the Treatment of Paroxysmal Atrial Fibrillation
Scientific title
A First In Human Radiofrequency (RF) Balloon Catheter Ablation to Isolate Pulmonary Veins in the Treatment of Patients with Paroxysmal Atrial Fibrillation
Secondary ID [1] 287590 0
Nil
Universal Trial Number (UTN)
U1111-1175-1054
Trial acronym
AF-FICIENT AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 296382 0
paroxysmal atrial fibrillation 296383 0
Condition category
Condition code
Cardiovascular 296656 296656 0 0
Other cardiovascular diseases
Surgery 296996 296996 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Apama RF Balloon Catheter system used for radiofrequency ablation; RF energy administered to tissue at 8-10 Watts power over durations of 60 - 90 seconds with irrigation of 30 ml/minute. 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.
Intervention code [1] 292987 0
Treatment: Devices
Intervention code [2] 292988 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296267 0
Acute Safety assessed by the ability to deliver radiofrequency ablation with absence of device or procedure related serious adverse events following the procedure. Risks associated with this procedure are equal to those of other electrophysiological cardiac procedures including heart rhythm disturbances, blood clots, ischemic event. Transthoracic Echocardiography will be performed at discharge or 7 days post procedure whichever occurs first.
Timepoint [1] 296267 0
Echocardiography performed at 7 days post procedure
Secondary outcome [1] 318015 0
Performance based on the clinical success of pulmonary vein isolation as defined by 12 lead ECG and Transthoracic Echo to confirm pulmonary vein isolation and confirmation of exit or block.
Timepoint [1] 318015 0
30 days post procedure

Eligibility
Key inclusion criteria
History of symptomatic paroxysmal and atrial fibrillation within the past year documented by ECG
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2016
Actual
8/03/2016
Date of last participant enrolment
Anticipated
14/12/2018
Actual
30/11/2019
Date of last data collection
Anticipated
Actual
31/12/2019
Sample size
Target
125
Accrual to date
Final
127
Recruitment outside Australia
Country [1] 7202 0
New Zealand
State/province [1] 7202 0
Christchurch
Country [2] 7203 0
New Zealand
State/province [2] 7203 0
Wellington
Country [3] 7204 0
Paraguay
State/province [3] 7204 0
Asuncion
Country [4] 7205 0
Czech Republic
State/province [4] 7205 0
Prague
Country [5] 22358 0
Lithuania
State/province [5] 22358 0
Vilnius

Funding & Sponsors
Funding source category [1] 292152 0
Commercial sector/Industry
Name [1] 292152 0
Apama Medical
Country [1] 292152 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific
Address
Lambroekstraat 5D, 1831 Diegem
Country
Belgium
Secondary sponsor category [1] 290825 0
None
Name [1] 290825 0
None
Address [1] 290825 0
Country [1] 290825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293628 0
Health and Disability Ethics Committees
Ethics committee address [1] 293628 0
Ministry of Health
C/-MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013 Wellington 6011
Ethics committee country [1] 293628 0
New Zealand
Date submitted for ethics approval [1] 293628 0
20/10/2015
Approval date [1] 293628 0
11/11/2015
Ethics approval number [1] 293628 0

Summary
Brief summary
The study is intended to assess the safety and preliminary performance data for treatment of symptomatic paroxysmal atrial fibrillation using the Apama Cardiac Ablation System. The study will be a prospective, multicenter, non-randomized investigation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60746 0
Prof Ian Crozier
Address 60746 0
Christchurch Hospital
2 Riccarton Avenue
PO Bag 4710
Christchurch 8140
Country 60746 0
New Zealand
Phone 60746 0
+643640640
Fax 60746 0
+6433786378
Email 60746 0
[email protected]
Contact person for public queries
Name 60747 0
Allison Anderson
Address 60747 0
Boston Scientific
4100 Hamline Ave. Arden Hills, MN 55110 (Allison Anderson)
Country 60747 0
United States of America
Phone 60747 0
+16515825077
Fax 60747 0
Email 60747 0
[email protected]
Contact person for scientific queries
Name 60748 0
Allison Anderson
Address 60748 0
Boston Scientific
4100 Hamline Ave. Arden Hills, MN 55110 (Allison Anderson)
Country 60748 0
United States of America
Phone 60748 0
+16515825077
Fax 60748 0
Email 60748 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
Study results articleYes A Novel Visually Guided Radiofrequency Balloon Abl... [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
EmbasePulsed Field Ablation to Treat Atrial Fibrillation: Autonomic Nervous System Effects.2023https://dx.doi.org/10.1016/j.jacep.2022.10.028
N.B. These documents automatically identified may not have been verified by the study sponsor.