Trials / Completed
CompletedNCT06023290
Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Ziekenhuis Oost-Limburg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Heart rhythm measurements with Preventicus® | The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. |
| DIAGNOSTIC_TEST | Heart rhythm measurements with FibriCheck® | The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. |
| DIAGNOSTIC_TEST | Heart rhythm measurements with Apple Watch® | The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. |
| DIAGNOSTIC_TEST | Heart rhythm measurements with 6L Kardia Mobile® | The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard. |
Timeline
- Start date
- 2023-07-03
- Primary completion
- 2023-10-27
- Completion
- 2023-11-17
- First posted
- 2023-09-05
- Last updated
- 2023-12-01
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT06023290. Inclusion in this directory is not an endorsement.