Trials / Unknown
UnknownNCT05668377
Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- PulseAI Ltd · Industry
- Sex
- All
- Age
- 22 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).
Detailed description
Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG. The arrhythmias will include: * Atrial Fibrillation/Flutter * Tachycardia * Bradycardia * Premature Atrial Contractions * Premature Ventricular Contractions
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PulseAI ECG Platform | Cloud-based AI-enabled ECG analysis platform |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2022-12-29
- Last updated
- 2022-12-29
Locations
1 site across 1 country: Ireland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05668377. Inclusion in this directory is not an endorsement.