Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000887774
Ethics application status
Approved
Date submitted
14/06/2022
Date registered
22/06/2022
Date last updated
4/07/2022
Date data sharing statement initially provided
22/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Smartphone Application to Detect Atrial Fibrillation After Ablation Procedure
Scientific title
Detection of Atrial Fibrillation Recurrence Post-Ablation Using Photoplethysmography-Based Smartphone App (FibriCheck)
Secondary ID [1] 307341 0
Nil known
Universal Trial Number (UTN)
U1111-1279-3675
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 326632 0
Condition category
Condition code
Cardiovascular 323878 323878 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-randomised trial where each participant will undergo concurrent monitoring using Holter and FibriCheck application on their smartphones at specific time frame for specific duration (stated below).
Patients with symptomatic atrial fibrillation (AF) undergoing AF ablation procedure will be asked to use FibriCheck application on their smartphones to measure their heart rhythm. The app is available through the App Store and the subscription code will be provided to the participants for free thoughout the study duration. Participants will be provided both a written and oral instructions on how to use the app. Instructions are also readily available online at https://pages.fibricheck.com/ifu/app/2.1.3/en/.
To start measuring, participants will be instructed to be in the seated position with the arm resting on a table, placing their (index) finger on the camera of the smartphone for 60 seconds. Participants will be asked to measure twice daily for a period of 28-days at an interval of every 3-months post-ablation for the duration of the study (3-month, 6-month, 9-month and 12-month). They will also be asked to take additional measurements at any point during the 28-days period if they experience any symptom (e.g palpitation, light headed, fatigue, chest pain, etc). Participants' adherence to monitoring schedule will be assess by accessing app analytics.
The monitoring duration will also be scheduled to coincide with standard post-ablation clinic follow up with concurrent 4-day Holter monitoring at 3-monthly intervals. The overall duration of this study is 12 months.
Intervention code [1] 323775 0
Diagnosis / Prognosis
Intervention code [2] 323807 0
Early detection / Screening
Comparator / control treatment
Participants will undergo 4-day Holter monitoring at 3-monthly intervals (3-month, 6-month, 9-month and 12-month) post ablation. The Holter monitor will be fitted to participants by trained technicians at the outpatient clinic. Once the Holter monitor is fitted, participants will receive instructions on how to wear it and return to everyday activities. The Holter monitor will be worn for 4 consecutive days. Participants will be asked to note if and when they have any symptom while wearing the Holter monitor. Once the monitoring period is over, the device will be returned to the outpatient clinic for analysis.
Control group
Active

Outcomes
Primary outcome [1] 331690 0
Detection of post-ablation AF recurrence by the FibriCheck app
Timepoint [1] 331690 0
3-month, 6-month, 9-month and 12-month post ablation
Primary outcome [2] 331733 0
Detection of post-ablation AF recurrence by Holter monitor
Timepoint [2] 331733 0
3-month, 6-month, 9-month and 12-month post ablation. Changes made prior to enrolment commencement
Secondary outcome [1] 410797 0
Adherence to the scheduled photoplethysmography (PPG) measurements - by accessing app analytics
Timepoint [1] 410797 0
3-month, 6-month, 9-month and 12-month post ablation.
Secondary outcome [2] 410901 0
FibriCheck app usage questionnaire as reported by the participants using study-specific questionnaire
Timepoint [2] 410901 0
12-month post ablation

Eligibility
Key inclusion criteria
• Patients with symptomatic AF undergoing AF ablation procedure
• Aged 18 years or older
• Owner of a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with implantable cardiac devices e.g pacemakers
• Inability to use a smartphone app due to physical, visual or cognitive impairment
• Unwilling or unable to comply fully with study procedures and follow-up

Study design
Purpose of the study
Diagnosis
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the estimation of our sample size, we used an estimated prevalence of AF recurrence following ablation detected by Holter monitor at 30% as previously reported. Based on a previous study, sensitivity for Holter detection of AF recurrence is estimated at 40% and FibriCheck at 70%. The minimum sample size for this study to provide 80% power at 0.05 significance level is 98, based on Equivalence Tests for Pairwise Proportion Differences in a Williams Cross-Over Design, with a drop-out rate of 20%.

Statistical analysis will be conducted with Stata version 16 (StataCorp, College Station, Texas, United States). Descriptive statistics will be presented for continuous variables using mean±SD or median (Q1 to Q3) according to the distribution. Categorical variables will be summarized with numbers and percentages. Group comparisons for continuous variables will be analyzed using Mann-Whitney U tests while for categorical variables, Chi-squared tests will be performed to assess differences between the groups. Atrial fibrillation detection rates with FibriCheck and Holter monitoring will be evaluated and agreement between the two methods will be determined with Cohen's kappa coefficient. A p-value of = 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2022
Actual
Date of last participant enrolment
Anticipated
28/04/2023
Actual
Date of last data collection
Anticipated
28/04/2024
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22553 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 22554 0
Ashford Community Hospital - Ashford
Recruitment postcode(s) [1] 37794 0
5000 - Adelaide
Recruitment postcode(s) [2] 37795 0
5035 - Ashford

Funding & Sponsors
Funding source category [1] 311632 0
University
Name [1] 311632 0
University of Adelaide
Country [1] 311632 0
Australia
Primary sponsor type
University
Name
UNIVERSITY OF ADELAIDE
Address
The University of Adelaide (Adelaide)
230 North Tce
SA 5005
Country
Australia
Secondary sponsor category [1] 313069 0
None
Name [1] 313069 0
Address [1] 313069 0
Country [1] 313069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311089 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee
Ethics committee address [1] 311089 0
Ethics committee country [1] 311089 0
Australia
Date submitted for ethics approval [1] 311089 0
13/05/2022
Approval date [1] 311089 0
07/06/2022
Ethics approval number [1] 311089 0
16473

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

Contacts
Principal investigator
Name 119902 0
Prof PRASHANTHAN SANDERS
Address 119902 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
Country 119902 0
Australia
Phone 119902 0
+618 70741804
Fax 119902 0
Email 119902 0
[email protected]
Contact person for public queries
Name 119903 0
SURAYA HANI KAMSANI
Address 119903 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
Country 119903 0
Australia
Phone 119903 0
+61 8 8128 4488
Fax 119903 0
Email 119903 0
[email protected]
Contact person for scientific queries
Name 119904 0
SURAYA HANI KAMSANI
Address 119904 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000
Country 119904 0
Australia
Phone 119904 0
+61 8 8128 4488
Fax 119904 0
Email 119904 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
Ethics approval did not include informed consent from participants to share data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16364Study protocol    384211-(Uploaded-14-06-2022-12-47-55)-Study-related document.pdf
16365Informed consent form    384211-(Uploaded-14-06-2022-12-48-20)-Study-related document.pdf
16366Ethical approval    384211-(Uploaded-14-06-2022-12-48-36)-Study-related document.pdf



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.