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Completed

NCT Number: NCT06028893

REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (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®).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heart rhythm measurements with FibriCheck®

Diagnostic Test

Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.

Heart rhythm measurements with Kardia Mobile®

Diagnostic Test

Measurements are performed immediately before and after every FibriCheck® measurement.

Primary outcomes

  1. Sensitivity

    Time frame: Two months

    Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.

  2. Specificity

    Time frame: Two months

    Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.

  3. Overall accuracy (proportion of correct classifications)

    Time frame: Two months

    Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.

Secondary outcomes

  1. Positive predictive value

    Time frame: Two months

    Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.

  2. Negative predictive value

    Time frame: Two months

    Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.

  3. 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®.

  4. 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®.

  5. Accuracy by heart rate interval

    Time frame: Two months

    Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.

  6. Proportion of PPG measurements of insufficient quality for rhythm analysis

    Time frame: Two months

    PPG measurements by FibriCheck®.

  7. Proportion of ECG measurements of insufficient quality for rhythm analysis

    Time frame: Two months

    ECG measurements by Kardia Mobile®.

  8. Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval

    Time frame: Two months

    PPG measurements by FibriCheck®.

  9. Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval

    Time frame: Two months

    ECG measurements by Kardia Mobile®.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

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

Acronym: RELATION PPG

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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