The Validation of the FibriCheck Application for the Detection of Atrial Fibrillation (FLASH-AF)

FLASH-AF: The Validation of the FibriCheck Application for the Detection of Atrial Fibrillation

Optical sensing technologies have the potential to enable long-term heart rhythm monitoring. The medically certified and clinically validated FibriCheck technology has proven its value for spot-check measurements to detect AF. However, further validation and verification of this technology is necessary to evaluate the performance of the FibriCheck technology on different tools (smartphones and smartwatches). During this study the performance of various optical sensors, ranging from the camera in smartphones to the photodetector in smartwatches, will be explored and device and form-factor variability will be investigated. The objective is to define the accuracy of optical sensing systems in the detection of atrial fibrillation versus a reference traditional 12-lead ECG signal.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: FibriCheck

Detailed Description

During this study the performance of various optical sensors, ranging from the camera in smartphones to the photodetector in smartwatches, will be explored and device and form-factor variability will be investigated. The objective is to define the accuracy of optical sensing systems in the detection of atrial fibrillation versus a reference traditional 12-lead ECG signal. Therefore, 2 groups will be created where different technologies will be investigated i.e. Group 1 will use various mobile devices and Group 2 will use various wearable devices. The recruitment of patients will be carried out in the framework of the usual care practice, where patients can be recruited at different moments throughout their current care-cycle.

Group 1: Smartphone based sensor: Here, the user needs to place the finger on the smartphone camera for 60 seconds to obtain high quality PPG waveforms. These waveforms are analysed using automated algorithms and stored under a unique anonymized study ID.

Group 2: Smartwatch based sensor: Here, a wearable device is used that is placed on the wrist and will record a PPG signal, similar as the smartphone camera, but with a specific PPG sensor. The data is extracted and processed by the FibriCheck software and the algorithms generate a diagnostic output which is stored under a unique anonymized study ID.

The hardware involved originates from different providers. Since FibriCheck is certified as stand-alone software, it is expected that it functions independently from different hardware sources. This hypothesis will be addressed in this study.

Smartphone devices that will be used in this research: Samsung, Huawei, Xiaomi, Apple, LGE, Lenovo and ZTE devices. Wearable devices that will be used in this research: Apple and Fitbit smartwatch devices.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with and without atrial fibrillation (based on 12-lead ECG) presenting at the cardiology ward for standard consultations or admitted for observation or cardiac interventions will be recruited.

Description

Inclusion Criteria:

• 18 years or older

Exclusion Criteria:

• Pacemaker dependent heart rhythm
• Tremor or Parkinson's disease
• Barriers for communication and lack of capability to execute the handlings required for this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The smartphone group; Patients recruited from the cardiology ward where 10 different smartphone devices will be used for the recording of PPG signals with the FibriCheck application. These recordings will be compared with single-lead ECG recorded with an AliveCor Smartphone devices and gold-standard 12-lead ECG to determine the diagnostic accuracy.	Diagnostic test: FibriCheck; Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm
The smartwatch group; Patients recruited from the cardiology ward where 2 different wearable devices will be used for the recording of PPG signals with the FibriCheck application. These recordings will be compared with single-lead ECG recorded with an AliveCor wearable and gold-standard 12-lead ECG to determine the diagnostic accuracy.	Diagnostic test: FibriCheck; Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy to identify atrial fibrillation	Assessment of the diagnostic accuracy of the FibriCheck smartphone or smartwatch application to detect atrial fibrillation on devices with various technical aspects. The diagnostic accuracy will be determined by comparing the FibriCheck diagnosis with the diagnosis of a gold-standard 12-lead ECG. Differences in diagnostic accuracy of FibriCheck on different hardware devices will be evaluated.	July 2019

Collaborators and Investigators

• Sponsor: Qompium NV
• Investigators: Study Director: Lars Grieten, PhD, CEO

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Validation; Atrial Fibrillation; Smartphone; Smartwatch; FibriCheck
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No