REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection) (RELATION PPG)

October 23, 2023 updated by: Ziekenhuis Oost-Limburg

A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection

Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
  • Subject provides informed consent.
  • Subject understands and agrees to comply with planned study procedures.
  • Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.

Exclusion Criteria:

  • Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
  • No access to a smartphone or unable to perform FibriCheck measurements at home.
  • Pacemaker.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
All subjects will perform heart rhythm measurements with both diagnostic tests.
Diagnostic test: Heart rhythm measurements with FibriCheck®
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
Diagnostic test: Heart rhythm measurements with Kardia Mobile®
Measurements are performed immediately before and after every FibriCheck® measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Two months
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Two months
Specificity
Time Frame: Two months
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Two months
Overall accuracy (proportion of correct classifications)
Time Frame: Two months
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value
Time Frame: Two months
Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Two months
Negative predictive value
Time Frame: Two months
Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Two months
Sensitivity by heart rate interval
Time Frame: Two months
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Two months
Specificity by heart rate interval
Time Frame: Two months
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Two months
Accuracy by heart rate interval
Time Frame: Two months
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis
Time Frame: Two months
PPG measurements by FibriCheck®.
Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis
Time Frame: Two months
ECG measurements by Kardia Mobile®.
Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
Time Frame: Two months
PPG measurements by FibriCheck®.
Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
Time Frame: Two months
ECG measurements by Kardia Mobile®.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuis Oost-Limburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-2021058-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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