Trials / Enrolling By Invitation
Enrolling By InvitationNCT06749145
Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Accepted
Summary
The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Portable 1-lead electrocardiogram | Portable 1-lead electrocardiogram (ECG) performed with the FDA-approved AliveCor KardiaMobile device. |
| DIAGNOSTIC_TEST | Point-of-care ultrasound | Point-of-care ultrasound performed with the FDA-approved VScan Air device. |
| OTHER | AI-ECG risk algorithm | Artificial intelligence (AI) risk algorithm for aortic stenosis using a 1-lead electrocardiogram |
| OTHER | AI-POCUS | Artificial intelligence (AI) risk algorithm for aortic stenosis using cardiac ultrasound plax videos. |
Timeline
- Start date
- 2025-09-16
- Primary completion
- 2028-08-31
- Completion
- 2028-08-31
- First posted
- 2024-12-27
- Last updated
- 2025-11-26
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06749145. Inclusion in this directory is not an endorsement.