A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's
NCT ID: NCT06290570
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-05-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hypertrophic Cardiomyopathy (HCM)
Subjects with clinically validated diagnoses of HCM will be enrolled and have a clinically indicated 12-Lead ECG obtained as well as ECG tracings collected using an Apple Smart Watch (single-lead) and AliveCor KardiaMobile (6-Lead).
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.
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.
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.
Athlete's
Athlete's will be enrolled and have a clinically indicated 12-Lead ECG obtained as well as ECG tracings collected using an Apple Smart Watch (single-lead) and AliveCor KardiaMobile (6-Lead).
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Konstantinos Siontis
Principal Investigator
Principal Investigators
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Konstantinos Siontis, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Heart Rhythm Services Research Team
Role: primary
Other Identifiers
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23-007685
Identifier Type: -
Identifier Source: org_study_id
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