REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)
NCT06028893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-10-26
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®).
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Ziekenhuis Oost-Limburg
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-01
- Primary Completion
- 2023-08-31
- Completion
- 2023-08-31
- FDA Device
- Yes
Countries
- Belgium
Study Locations
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