HealthyPROCESSNCT05450809
Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to 2 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ambulatory patients who are undergoing a clinically ordered electrocardiogram in the Mayo Clinic outpatient ECG lab.
Who may be able to join
- Age ≥ 18 years and ≤ 89.
- Able to give verbal consent.
- Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.
Who cannot join
- Individuals < 18 and > 89 years of age.
- Unable to given verbal consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PeRfOrmance and ACcuracy of an artifiCial Intelligence Enhanced Smart Watch Single Lead ECG (PROCESS)
The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.
Read the detailed description
- Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.
- Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.
- This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG
- Conditions
- Healthy
- Keywords
- electrocardiogram, wearable, artificial intellegence, Apple Watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory, outpatient Mayo Clinic ECG lab patients | Patients who are undergoing routine clinical evaluation with a 12 lead ECG recording ordered at the Mayo Clinic ECG lab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 12 lead ECG features to single-lead watch-based ECG features
The ECG interval differences (in milliseconds) between 12 Lead and collected single-lead watch-based ECG for PR, QRS, QT intervals will be determined and compared for each patient.
Measured: 12 months
Arrhythmia comparison of 12 lead ECG to single-lead watch-based ECG
A physician interpretation of patients' 12 lead ECG and single-lead watch-based ECG will be performed to determined underlying rhythm (i.e. sinus rhythm, atrial fibrillation etc) from each, and the results from these modalities will be compared.
Measured: 12 months
Secondary outcomes (1)
Arrhythmia classification by physician overread of single-lead watch-based ECG
A physician interpretation of the patient's single-lead watch-based ECG will occur as described in "Outcome 2." The results of this ECG interpretation (i.e. sinus rhythm, atrial fibrillation, or inconclusive) will be compared to the watch/app-based rhythm auto-classification for each recorded single-lead watch-based ECG.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start5 Nov 2021
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itzhak Zachi Attia, Mayo Clinic
- Investigators
- Itzhak Zachi Attia, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450809
- Sponsor's protocol ID
- 21-006770
- Acronym
- PROCESS
- Status last verified
- Dec 2022
- First submitted
- 5 Jul 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality and IRB rules, we will not make individual patient data available
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeRfOrmance and ACcuracy of an artifiCial Intelligence Enhanced Smart Watch Single Lead ECG (PROCESS)
- ClinicalTrials.gov ID
- NCT05450809
- Acronym / sponsor ID
- PROCESS / 21-006770
- Conditions
- Healthy
- Keywords
- electrocardiogram, wearable, artificial intellegence, Apple Watch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 11 Jul 2022 (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 show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.
Detailed description
- Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.
- Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.
- This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory, outpatient Mayo Clinic ECG lab patients | – | –Patients who are undergoing routine clinical evaluation with a 12 lead ECG recording ordered at the Mayo Clinic ECG lab. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory patients who are undergoing a clinically ordered electrocardiogram in the Mayo Clinic outpatient ECG lab.
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 89.
- Able to give verbal consent.
- Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.
Key exclusion criteria (2 listed)
- Individuals < 18 and > 89 years of age.
- Unable to given verbal consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of 12 lead ECG features to single-lead watch-based ECG features
Time frame: 12 months
The ECG interval differences (in milliseconds) between 12 Lead and collected single-lead watch-based ECG for PR, QRS, QT intervals will be determined and compared for each patient.
Arrhythmia comparison of 12 lead ECG to single-lead watch-based ECG
Time frame: 12 months
A physician interpretation of patients' 12 lead ECG and single-lead watch-based ECG will be performed to determined underlying rhythm (i.e. sinus rhythm, atrial fibrillation etc) from each, and the results from these modalities will be compared.
1 secondary outcome
Arrhythmia classification by physician overread of single-lead watch-based ECG
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to patient confidentiality and IRB rules, we will not make individual patient data available
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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.
Itzhak Zachi Attia, PhD 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 Healthy, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 28 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of 12 lead ECG features to single-lead watch-based ECG features (time frame: 12 months). 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 28 Dec 2022.