Trials / Completed
CompletedNCT04792905
Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm
Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (actual)
- Sponsor
- Cardiologs Technologies · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This observational exploratory prospective study will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)
Detailed description
After being informed about the study, participants hospitalized for ablation or cardioversion or having a cardiac rhythm consultation at the investigational center will have Apple Watch ECG recordings done simultaneously with 12-lead ECG measurements performed in accordance with the existing in-stay subject monitoring protocol. AI-AW will be compared to standard manual 12-lead ECG reviewed by cardiologists for AF detection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cardiologs | Two Apple Watch recordings (one recording with the watch on the wrist and one on the left side of the abdomen) interpreted by Cardiologs AI done simultaneously with each 12-lead ECG |
Timeline
- Start date
- 2021-03-30
- Primary completion
- 2021-07-19
- Completion
- 2021-07-19
- First posted
- 2021-03-11
- Last updated
- 2021-09-08
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04792905. Inclusion in this directory is not an endorsement.