Trials / Completed
CompletedNCT06609174
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | KardiaRx ECG Screening and AI interpretation of ECG | The Kardia 6-lead device is an ambulatory, wireless device that connects to a smartphone. The KardiaRx App processes the signal acquired from the Kardia device into a real-time ECG. ECG will be interpreted by an AI algorithm |
Timeline
- Start date
- 2024-10-18
- Primary completion
- 2025-09-26
- Completion
- 2025-09-26
- First posted
- 2024-09-24
- Last updated
- 2025-11-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06609174. Inclusion in this directory is not an endorsement.