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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

NCT06290570•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

May 7, 2024

Primary Completion Date

June 25, 2025

Completion Date

December 1, 2026

Last Updated

March 19, 2026

Enrollment

183

ESTIMATED participants

Conditions

Hypertrophic Cardiomyopathy

Interventions

12-Lead ECG

DIAGNOSTIC_TEST

Apple Smart Watch Single Lead ECG

DIAGNOSTIC_TEST

AliveCor KardiaMobile 6-Lead ECG

DIAGNOSTIC_TEST

Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM

NCT05836259

Hypertrophic Cardiomyopathy

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RECRUITING

HCMR Re-Imaging Study

NCT07054073

Hypertrophic Cardiomyopathy (HCM)

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RECRUITING

Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM)

NCT07344480

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM

HCMR Re-Imaging Study

Retrospective Natural History Study of RASopathy-associated Cardiomyopathy (RAS-CM)

Myocardial Perfusion CMR for Differentiating and Characterizing Hypertrophic Cardiomyopathy Phenotypes

Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy

Multimodal Analysis of Endomyocardial Biopsies