Trials / Completed
CompletedNCT06028893
REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)
A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Ziekenhuis Oost-Limburg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-12-01
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
- First posted
- 2023-09-08
- Last updated
- 2023-10-26
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06028893. Inclusion in this directory is not an endorsement.