REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)
RELATION PPG
A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection
1 other identifier
interventional
50
1 country
1
Brief 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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Dec 2022
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedOctober 26, 2023
August 1, 2023
9 months
August 31, 2023
October 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sensitivity
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Two months
Specificity
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)
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Two months
Secondary Outcomes (9)
Positive predictive value
Two months
Negative predictive value
Two months
Sensitivity by heart rate interval
Two months
Specificity by heart rate interval
Two months
Accuracy by heart rate interval
Two months
- +4 more secondary outcomes
Study Arms (1)
Study group
EXPERIMENTALAll subjects will perform heart rhythm measurements with both diagnostic tests.
Interventions
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
Measurements are performed immediately before and after every FibriCheck® measurement.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 8, 2023
Study Start
December 1, 2022
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
October 26, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share