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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-07

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically validated diagnoses of HCM (n=150) and athlete's (n=150) will be identified by pre-screening of the clinic appointments for each of the specialty HCM and Sports Cardiology clinics or in the CV fellows' clinic (in patients with an established diagnosis and no pending testing). All diagnoses will need to be supported by unequivocal imaging and other ancillary data per our standard of care and at the determination of clinic experts.

Exclusion Criteria

* Any exception to the above criteria.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Siontis

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shaun Crawford

Role: CONTACT

507-422-5666

Konstantinos Siontis, MD

Role: CONTACT

(507) 255-1051

Facility Contacts

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Heart Rhythm Services Research Team

Role: primary

(507) 255-0774

Konstantinos Siontis, MD

Role: backup

(507) 255-1051

Other Identifiers

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23-007685

Identifier Type: -

Identifier Source: org_study_id

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