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CompletedNCT06028893RELATION PPGUpdated Oct 26, 2023

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

An interventional study of Heart rhythm measurements with FibriCheck® and Heart rhythm measurements with Kardia Mobile® in Atrial Fibrillation, sponsored by Ziekenhuis Oost-Limburg. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 1 month ago, and no results have been posted to the registry.
  • Registered 8 months after the study started (first participant enrolled Dec 2022, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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®).

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
  • Photoplethysmography
  • Single-lead ECG
  • Electrocardiogram
  • Digital Health
03

In context

Atrial Fibrillation

3,958 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 50 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Study group

    All subjects will perform heart rhythm measurements with both diagnostic tests.

    Diagnostic Test: Heart rhythm measurements with FibriCheck® · Diagnostic Test: Heart rhythm measurements with Kardia Mobile®

Interventions

  • Diagnostic testHeart 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 testHeart rhythm measurements with Kardia Mobile®

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

06

What researchers measure

Primary outcomes

  1. Sensitivity

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

    Time frame: Two months

  2. Specificity

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

    Time frame: Two months

  3. Overall accuracy (proportion of correct classifications)

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

    Time frame: Two months

Secondary outcomes

  1. Positive predictive value

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

    Time frame: Two months

  2. Negative predictive value

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

    Time frame: Two months

  3. Sensitivity by heart rate interval

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

    Time frame: Two months

  4. Specificity by heart rate interval

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

    Time frame: Two months

  5. Accuracy by heart rate interval

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

    Time frame: Two months

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

    PPG measurements by FibriCheck®.

    Time frame: Two months

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

    ECG measurements by Kardia Mobile®.

    Time frame: Two months

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

    PPG measurements by FibriCheck®.

    Time frame: Two months

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

    ECG measurements by Kardia Mobile®.

    Time frame: Two months

07

Study locations

1 site
  • Ziekenhuis Oost-Limburg
    Genk, Limburg 3600, Belgium
08

References and documents

Publications

  • Gruwez H, Ezzat D, Van Puyvelde T, Dhont S, Meekers E, Bruckers L, Wouters F, Kellens M, Van Herendael H, Rivero-Ayerza M, Nuyens D, Haemers P, Pison L. Real-world validation of smartphone-based photoplethysmography for rate and rhythm monitoring in atrial fibrillation. Europace. 2024 Mar 30;26(4):euae065. doi: 10.1093/europace/euae065. PubMed 38630867 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2022 to primary completion in Aug 2023, 8 months.

Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 8 months is below that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2023
First posted
Sep 8, 2023
StartActual
Dec 1, 2022
Primary completionActual
Aug 31, 2023
CompletionActual
Aug 31, 2023
Last update
Oct 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06028893
Lead sponsor
Ziekenhuis Oost-Limburg
Responsible party
Sponsor
First posted
Sep 8, 2023
Start date
Dec 1, 2022
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Oct 26, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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