Hypertrophic CardiomyopathyNCT06290570
A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's
An observational study of Hypertrophic Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- 12-Lead ECG, Apple Smart Watch Single Lead ECG and AliveCor KardiaMobile 6-Lead ECG
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients scheduled for appointments in the sports cardiology or HCM clinic at Mayo Clinic in Rochester, MN will be approached to participate in the study.
Who may be able to join
- 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.
Who cannot join
- Any exception to the above criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prospective Evaluation of Artificial Intelligence ECG With Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction From Athlete's
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
- Being tested
- 12-Lead ECG, Apple Smart Watch Single Lead ECG, AliveCor KardiaMobile 6-Lead ECG
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-Lead ECGDiagnostic 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 ECGDiagnostic 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 ECGDiagnostic test
A 6-lead ECG tracing will be collected using an AliveCor KardiaMobile device and tracing will be used for AI-ECG analyses.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: 12-Lead ECG; Diagnostic Test: Apple Smart Watch Single Lead ECG; Diagnostic Test: AliveCor KardiaMobile 6-Lead ECG | |
| 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). Receives: Diagnostic Test: 12-Lead ECG; Diagnostic Test: Apple Smart Watch Single Lead ECG; Diagnostic Test: AliveCor KardiaMobile 6-Lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of AI-ECG probabilities in HCM
Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead) in subjects with HCM. The AI scores will be utilized to generate the AI-ECG probability of accurately diagnosing HCM (labelled as true positive, true negative, false positive, false negative) and the distribution of AI-ECG probabilities will be evaluated. A higher distribution of AI-ECG probabilities (more true positives) will reflect better diagnostic performance of the AI-ECG Algorithm.
Measured: Baseline
Comparative diagnostic performance between tracings obtained from different devices
Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead). Diagnostic performance of AI Algorithm (labelled as true positive, true negative, false positive, false negative) based on tracing from each ECG form factor (12-lead, single-lead, 6-lead) will be evaluated and compared.
Measured: Baseline
Secondary outcomes (2)
Distribution of AI-ECG probabilities in Athlete's
Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead) in subjects with Athlete's. The AI scores will be utilized to generate the AI-ECG probability of accurately diagnosing HCM (true positive, true negative, false positive, false negative) and the distribution of AI-ECG probabilities will be evaluated. A higher distribution of AI-ECG probabilities (more true positives) will reflect better diagnostic performance of the AI-ECG Algorithm.
Measured: Baseline
Correlation with false negative AI ECG result
Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead). Diagnostic performance of AI Algorithm (labelled as true positive, true negative, false positive, false negative) based on tracing from each ECG form factor (12-lead, single-lead, 6-lead) will be evaluated and the correlation of the form factor to a false negative AI ECG result will be determined.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start7 May 2024
- Primary completion25 Jun 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Siontis, Mayo Clinic
- Investigators
- Konstantinos Siontis, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290570
- Sponsor's protocol ID
- 23-007685
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Artificial Intelligence ECG With Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction From Athlete's
- ClinicalTrials.gov ID
- NCT06290570
- Acronym / sponsor ID
- 23-007685
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic Cardiomyopathy (HCM) | – | Diagnostic Test: 12-Lead ECG, Diagnostic Test: Apple Smart Watch Single Lead ECG, Diagnostic Test: AliveCor KardiaMobile 6-Lead ECGSubjects 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). |
| Athlete's | – | Diagnostic Test: 12-Lead ECG, Diagnostic Test: Apple Smart Watch Single Lead ECG, Diagnostic Test: AliveCor KardiaMobile 6-Lead ECGAthlete'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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients scheduled for appointments in the sports cardiology or HCM clinic at Mayo Clinic in Rochester, MN will be approached to participate in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any exception to the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-Lead ECGA 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 | Athlete's, Hypertrophic Cardiomyopathy (HCM) |
| Apple Smart Watch Single Lead ECGA single lead ECG tracing will be collected using an Apple Smart Watch and tracing will be used for AI-ECG analyses. | Diagnostic test | Athlete's, Hypertrophic Cardiomyopathy (HCM) |
| AliveCor KardiaMobile 6-Lead ECGA 6-lead ECG tracing will be collected using an AliveCor KardiaMobile device and tracing will be used for AI-ECG analyses. | Diagnostic test | Athlete's, Hypertrophic Cardiomyopathy (HCM) |
Primary outcome
Distribution of AI-ECG probabilities in HCM
Time frame: Baseline
Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead) in subjects with HCM. The AI scores will be utilized to generate the AI-ECG probability of accurately diagnosing HCM (labelled as true positive, true negative, false positive, false negative) and the distribution of AI-ECG probabilities will be evaluated. A higher distribution of AI-ECG probabilities (more true positives) will reflect better diagnostic performance of the AI-ECG Algorithm.
Comparative diagnostic performance between tracings obtained from different devices
Time frame: Baseline
Artificial Intelligence (AI) scores will be measured using the AI Algorithm on ECG tracings obtained from clinically indicated 12-Lead ECG, Apple Smart Watch (single-lead), and AliveCor KardiaMobile (6-Lead). Diagnostic performance of AI Algorithm (labelled as true positive, true negative, false positive, false negative) based on tracing from each ECG form factor (12-lead, single-lead, 6-lead) will be evaluated and compared.
2 secondary outcomes
Distribution of AI-ECG probabilities in Athlete's
Time frame: Baseline
Correlation with false negative AI ECG result
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Siontis, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of AI-ECG probabilities in HCM (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.