The Validation of the FibriCheck Application for the Detection of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— FLASH-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620656
• Other study ID #: 2
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: December 2019
• Source: Qompium NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 15, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• FibriCheck
Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Qompium NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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