Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias

Cardiac Arrhythmia Clinical Trial

— INTERPRET-AF I  

Official title:

Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias Using a Pulse-deriving Smartphone Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374344
• Other study ID #: 3
• Status: Completed
• Start date: March 10, 2020
• Est. completion date: November 24, 2020

Study information

• Verified date: December 2020
• Source: Qompium NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single-lead electrocardiography (ECG) technologies and photoplethysmography (PPG) deriving smartphone apps are gaining interest in the heart rhythm detection space since these apps have the potential to capture and assess heart rhythms. Proprietary arrhythmia detection algorithms are proven to be reliable and accurate. However, insights into the readability of PPG waveforms by human reviewers remain limited. To the investigators' knowledge, there are no publications available regarding the readability of PPG waveforms by human reviewers. The objective of the study was to assess the readability of PPG and single-lead ECG analysis by medical professionals, with respect to the gold-standard 12-lead ECG diagnosis, and investigate whether additional information positively impacts PPG analysis.

Description:

During the study, the readability of PPG and single-lead ECG waveform analysis will be investigated. The objective of the study is to determine the readability of PPG and single-lead ECG measurements, with respect to the gold-standard 12-lead ECG, and investigate whether additional information positively impacts the readability of PPG. Medical professionals (cardiologists and cardiology residents), blinded for the patients' characteristics and history, are instructed to separately analyse the following signals, obtained from 30 patients.

• 30 outputs with PPG waveforms

• 30 outputs with PPG waveforms with tachogram and Poincaré

• 30 outputs with PPG waveforms with tachogram, Poincaré, and algorithm interpretation

• 30 outputs with single-lead ECG waveforms

• 30 outputs with 12-lead ECG waveforms

Participants report the results of the qualitative analysis via a digital questionnaire with multiple-choice questions. Medical professionals classify each rhythm trace as regular rhythm, one or more ectopic/missed heartbeats, atrial flutter, atrial fibrillation, unreadable, or other. The tachogram, Poincaré, and the algorithm interpretation are subsequently added to investigate whether the additional information improves the readability of PPG. Based on the provided answers, the study team will determine the readability of PPG and single-lead ECG analysis interpretation, with respect to the gold-standard 12-lead ECG diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 24, 2020
• Est. primary completion date: November 24, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cardiologist or cardiology resident

• Able to understand Dutch or English

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Other:
• Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements
Participants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

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 discriminate between atrial fibrillation and non-atrial fibrillation rhythms	Readability assessment (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of PPG and single-lead ECG signals to detect atrial fibrillation. The readability will be determined and compared with the gold-standard 12-lead ECG diagnosis.	Through study completion, an average of 3 months
Secondary	Required elements to increase the readability of PPG measurements	Readability assessment (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of PPG waveforms, PPG waveforms with tachogram and Poincaré, and PPG waveforms with tachogram, Poincaré and algorithm interpretation. The readability will be determined and compared with the gold-standard 12-lead ECG diagnosis.	Through study completion, an average of 3 months
Secondary	Diagnostic accuracy of PPG analysis: experienced in PPG analysis vs inexperienced in PPG analysis	Readability assessment (sensitivity, specificity, positive predictive value, negative predictive value, and accuracy) of PPG waveforms, PPG waveforms with tachogram and Poincaré, and PPG waveforms with tachogram, Poincaré and algorithm interpretation. The readability will be determined and compared with the gold-standard 12-lead ECG diagnosis.	Through study completion, an average of 3 months