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AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
Sponsor: Mayo Clinic
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.
Official title: Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2024-10-18
Completion Date
2025-09-26
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States