ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

Diagnosis / Prognosis

Intervention code [2]

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]

Detection of post-ablation AF recurrence by the FibriCheck app

Timepoint [1]

3-month, 6-month, 9-month and 12-month post ablation

Primary outcome [2]

Detection of post-ablation AF recurrence by Holter monitor

Timepoint [2]

3-month, 6-month, 9-month and 12-month post ablation. Changes made prior to enrolment commencement

Secondary outcome [1]

Adherence to the scheduled photoplethysmography (PPG) measurements - by accessing app analytics

Timepoint [1]

3-month, 6-month, 9-month and 12-month post ablation.

Secondary outcome [2]

FibriCheck app usage questionnaire as reported by the participants using study-specific questionnaire

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Ashford Community Hospital - Ashford

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5035 - Ashford

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Adelaide

Address [1]

The University of Adelaide (Adelaide)
230 North Tce
SA 5005

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee

Ethics committee address [1]

Royal Adelaide Hospital
Clinical Trial Centre
Level 3, Wayfinder 3D460.02
Port Road
ADELAIDE SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/05/2022

Approval date [1]

07/06/2022

Ethics approval number [1]

16473

Summary

Brief summary

This research project seeks to investigate the use of a simple smartphone application (FibriCheck) in detecting atrial fibrillation (AF) recurrence after an AF ablation procedure. Early detection of AF recurrence is crucial to ensure proper and timely treatment. The study will compare FibriCheck with current monitoring strategy (Holter monitor) in identifying AF episodes. As short period of monitoring with Holter potentially miss episodes in between recording, FibriCheck could be a more superior and better tolerated alternative.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof PRASHANTHAN SANDERS

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000

Country

Australia

Phone

+618 70741804

Fax

prash.sanders@adelaide.edu.au

Contact person for public queries

Name

SURAYA HANI KAMSANI

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000

Country

Australia

Phone

+61 8 8128 4488

Fax

surayahani.kamasani@adelaide.edu.au

Contact person for scientific queries

Name

SURAYA HANI KAMSANI

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, SA 5000

Country

Australia

Phone

+61 8 8128 4488

Fax

surayahani.kamasani@adelaide.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Attachment
16364	Study protocol	384211-(Uploaded-14-06-2022-12-47-55)-Study-related document.pdf
16365	Informed consent form	384211-(Uploaded-14-06-2022-12-48-20)-Study-related document.pdf
16366	Ethical 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.

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