Trials / Completed
CompletedNCT03492554
Electrocardiogram Clinical Validation Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 602 (actual)
- Sponsor
- Apple Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 1-Lead ECG | All participants will record three single-lead ECGs |
| DEVICE | 12-Lead ECG | All participants will simultaneously record three 12-lead ECGs |
Timeline
- Start date
- 2018-03-12
- Primary completion
- 2018-05-14
- Completion
- 2018-05-14
- First posted
- 2018-04-10
- Last updated
- 2020-12-03
- Results posted
- 2019-07-24
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03492554. Inclusion in this directory is not an endorsement.