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

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ClinicalTrials.gov Identifier: NCT03620656
Recruitment Status : Not yet recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Qompium NV

Brief 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.

Condition or disease Intervention/treatment
Atrial Fibrillation 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: FLASH-AF: The Validation of the FibriCheck Application for the Detection of Atrial Fibrillation
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Diagnostic accuracy to identify atrial fibrillation [ Time Frame: July 2019 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620656


Contacts
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Contact: Pieter Vandervoort, MD 012345678 pieter.vandervoort@zol.be

Sponsors and Collaborators
Qompium NV
Investigators
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Study Director: Lars Grieten, PhD CEO

Additional Information:

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Responsible Party: Qompium NV
ClinicalTrials.gov Identifier: NCT03620656     History of Changes
Other Study ID Numbers: 2
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qompium NV:
Atrial Fibrillation
FibriCheck
Validation
Smartphone
Smartwatch
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes