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

NCT03620656 | Completed

• 1 other identifier: 2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; FibriCheck; Validation; Smartphone; Smartwatch

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

FibriCheck DIAGNOSTIC_TEST

Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm

The smartphone group; The smartwatch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older

You may not qualify if:

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

Sponsors & Collaborators

• Qompium NV: lead

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Grieten, PhD

  CEO

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 8, 2018
• Study Start: September 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: September 15, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

BE (1)