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

NCT ID: NCT03620656

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Keywords

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Atrial Fibrillation FibriCheck Validation Smartphone Smartwatch

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

FibriCheck

Intervention Type DIAGNOSTIC_TEST

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.

FibriCheck

Intervention Type DIAGNOSTIC_TEST

Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm

Interventions

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FibriCheck

Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qompium NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Grieten, PhD

Role: STUDY_DIRECTOR

CEO

Locations

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Ziekenhuis Oost Limburg

Genk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id