Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias

NCT04374344 | Completed

• 1 other identifier: 3
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrhythmia

Keywords

Qualitative analysis; Photoplethysmography; Single-lead electrocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Required elements to increase the readability of PPG measurements

  Through study completion, an average of 3 months

• Diagnostic accuracy of PPG analysis: experienced in PPG analysis vs inexperienced in PPG analysis

  Through study completion, an average of 3 months

Study Arms (1)

Medical professionals

Medical professionals including cardiologists and cardiology residents.

Other: Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements

Interventions

Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements OTHER

Participants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces.

Medical professionals

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical professionals including cardiologists and cardiology residents with and without experience in qualitative analysis of PPG waveforms.

You may qualify if:

• Cardiologist or cardiology resident
• Able to understand Dutch or English

Sponsors & Collaborators

• Qompium NV: lead

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Pieter Vandervoort, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 5, 2020
• Study Start: March 10, 2020
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

BE (1)