NCT06290570

A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's

Prospective Evaluation of Artificial Intelligence ECG With Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction From Athlete's

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 183 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	12-Lead ECG	A clinically performed 12-lead ECG tracing within 30 days of the appointment will be obtained from the subject medical record and will be used for AI-ECG analyses.
DIAGNOSTIC_TEST	Apple Smart Watch Single Lead ECG	A single lead ECG tracing will be collected using an Apple Smart Watch and tracing will be used for AI-ECG analyses.
DIAGNOSTIC_TEST	AliveCor KardiaMobile 6-Lead ECG	A 6-lead ECG tracing will be collected using an AliveCor KardiaMobile device and tracing will be used for AI-ECG analyses.

Timeline

• Start date: 2024-05-07
• Primary completion: 2025-06-25
• Completion: 2026-12-01
• First posted: 2024-03-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States