Heart Rate FastNCT03798613
Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
A study testing Apple Watch 4 Series Device and Continuous Telemetry Monitor in people with Heart Rate Fast and Heart Rate Low, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Rate Fast, Heart Rate Low
- What is being tested?
- Apple Watch 4 Series Device and Continuous Telemetry Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2018to 29 Mar 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus
Who cannot join
- Presence of a cardiac pacemaker
- Use of a radial artery graft for coronary artery bypass grafting
- Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be placed
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.
Read the detailed description
The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit.
During testing each subject will wear:
- An Apple Watch 4 series watch for no more than 5 minutes.
- Standard continuous telemetry monitor
The location of the watch (left or right wrist) will be randomly assigned.
Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor.
ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved for subsequent viewing and analysis.
Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at least two days, generating a minimum of six data points per patient.
After conclusion of the study for each subject, the ECG's from the health app pertaining to that subject will be reviewed by a board certified cardiologist as will the telemetry tracings.
In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time of enrollment.
- Conditions
- Heart Rate Fast, Heart Rate Low
- Being tested
- Apple Watch 4 Series Device, Continuous Telemetry Monitor
- Keywords
- Post-op Atrial Fibrillation, Heart Rhythm, Accuracy, Apple Watch
- Medical subject headings
- Tachycardia, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Watch 4 Series DeviceDevice
tracings from the apple watch 4 series watch
Continuous Telemetry MonitorDevice
tracings from the continuous telemetry monitor
| Study group | Role | What they receive |
|---|---|---|
| Apple Watch 4 Series Device | Active comparator | Apple watch 4 series heart rate monitoring device Receives: Device: Apple Watch 4 Series Device |
| Continuous Telemetry | Active comparator | Standard continuous telemetry monitoring device Receives: Device: Continuous Telemetry Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate accuracy compared to telemetry
Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
Measured: 5 minutes
Secondary outcomes (1)
Heart rhythm accuracy compared to telemetry
Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start21 Dec 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate FastStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Marc Gillinov, MD, The Cleveland Clinic
- Investigators
- Marc Gillinov, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798613
- Sponsor's protocol ID
- 18-1397
- Status last verified
- Apr 2019
- First submitted
- 21 Dec 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
- ClinicalTrials.gov ID
- NCT03798613
- Acronym / sponsor ID
- 18-1397
- Conditions
- Heart Rate Fast, Heart Rate Low
- Keywords
- Post-op Atrial Fibrillation, Heart Rhythm, Accuracy, Apple Watch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 10 Jan 2019 (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 objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.
Detailed description
The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit.
During testing each subject will wear:
- An Apple Watch 4 series watch for no more than 5 minutes.
- Standard continuous telemetry monitor
The location of the watch (left or right wrist) will be randomly assigned.
Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor.
ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved for subsequent viewing and analysis.
Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at least two days, generating a minimum of six data points per patient.
After conclusion of the study for each subject, the ECG's from the health app pertaining to that subject will be reviewed by a board certified cardiologist as will the telemetry tracings.
In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time of enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple Watch 4 Series Device | Active comparator | Device: Apple Watch 4 Series DeviceApple watch 4 series heart rate monitoring device |
| Continuous Telemetry | Active comparator | Device: Continuous Telemetry MonitorStandard continuous telemetry monitoring device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus
Key exclusion criteria (3 listed)
- Presence of a cardiac pacemaker
- Use of a radial artery graft for coronary artery bypass grafting
- Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be placed
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 |
|---|---|---|
| Apple Watch 4 Series Devicetracings from the apple watch 4 series watch | Device | Apple Watch 4 Series Device |
| Continuous Telemetry Monitortracings from the continuous telemetry monitor | Device | Continuous Telemetry |
Primary outcome
Heart rate accuracy compared to telemetry
Time frame: 5 minutes
Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
1 secondary outcome
Heart rhythm accuracy compared to telemetry
Time frame: 5 minutes
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 9 Apr 2019.
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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.
Marc Gillinov, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Watch 4 Series Device and Continuous Telemetry Monitor in people with Heart Rate Fast and Heart Rate Low, run by The Cleveland 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 2 inclusion and 3 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 9 Apr 2019. 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?
Heart rate accuracy compared to telemetry (time frame: 5 minutes). 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 9 Apr 2019.