MedDataX Logo

Qualitative Analysis of Photoplethysmography Waveforms for the Detection of Cardiac Arrhythmias

NCT ID: NCT04374344

Last Updated: 2020-12-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrhythmia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Qualitative analysis Photoplethysmography Single-lead electrocardiography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medical professionals

Medical professionals including cardiologists and cardiology residents.

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cardiologist or cardiology resident
* Able to understand Dutch or English
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qompium NV

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pieter Vandervoort, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ziekenhuis Oost Limburg

Genk, Limburg, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3

Identifier Type: -

Identifier Source: org_study_id