Arrhythmias, CardiacNCT05668377
Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
An observational study of Arrhythmias, Cardiac, run by PulseAI Ltd at 1 site in Ireland.
Trial summary
The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch). Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- PulseAI ECG Platform
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants hospitalised for ablation, cardioversion or cardiac rhythm consultation.
Who may be able to join
- Patient aged 22 or older, able and willing to participate in the study
- Patient admitted to hospital for ablation, cardioversion, or cardiac electrophysiological exploration.
- Patient who has read the information note and has given their consent before any procedure related to the study.
Who cannot join
- Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Beacon Hospital Research Institute
Dublin
David Burke, PhD
David Burke, PhD
About this study
The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).
Read the detailed description
Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG.
The arrhythmias will include:
- Atrial Fibrillation/Flutter
- Tachycardia
- Bradycardia
- Premature Atrial Contractions
- Premature Ventricular Contractions
- Conditions
- Arrhythmias, Cardiac
- Being tested
- PulseAI ECG Platform
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseAI ECG PlatformDevice
Cloud-based AI-enabled ECG analysis platform
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance of arrhythmia detection.
Evaluate the performance of arrhythmia detection by the PulseAI neural network applied to ECG data collected via the Smartwatch compared to physicians' interpretation of the 12-lead ECG.
Measured: 12 months
Secondary outcomes (2)
Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software
Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI neural network
Measured: 12 months
Evalaute the performance of QTc interval measurement
Evaluate the performance of QTc interval measurement by the PulseAI neural network applied to the Smartwatch ECG data compared to physicians' measure of the QTc interval from the 12-lead 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 posted29 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PulseAI Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beacon Hospital Research Institute, Dublin, Ireland
- Responsible party
- Sponsor
- Investigators
- David Burke, PhD, Principal investigator, Beacon Hospital Research Institute, Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668377
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2022
- First submitted
- 29 Sep 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
- ClinicalTrials.gov ID
- NCT05668377
- Acronym / sponsor ID
- 1
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PulseAI LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beacon Hospital Research Institute, Dublin, Ireland
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 29 Dec 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 study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).
Detailed description
Under subject consent, subjects will have a 12-lead ECG immediately followed by a smartwatch ECG. The heart rhythm and ECG interval measurements will be compared between the 12-lead ECG and smartwatch ECG.
The arrhythmias will include:
- Atrial Fibrillation/Flutter
- Tachycardia
- Bradycardia
- Premature Atrial Contractions
- Premature Ventricular Contractions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants hospitalised for ablation, cardioversion or cardiac rhythm consultation.
Key inclusion criteria (3 listed)
- Patient aged 22 or older, able and willing to participate in the study
- Patient admitted to hospital for ablation, cardioversion, or cardiac electrophysiological exploration.
- Patient who has read the information note and has given their consent before any procedure related to the study.
Key exclusion criteria (1 listed)
- Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
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 |
|---|---|---|
| PulseAI ECG PlatformCloud-based AI-enabled ECG analysis platform | Device | – |
Primary outcome
Evaluate the performance of arrhythmia detection.
Time frame: 12 months
Evaluate the performance of arrhythmia detection by the PulseAI neural network applied to ECG data collected via the Smartwatch compared to physicians' interpretation of the 12-lead ECG.
2 secondary outcomes
Evaluate the performance of the Apple Watch ECG interpretation Software compared to the PulseAI software
Time frame: 12 months
Evalaute the performance of QTc interval measurement
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Arrhythmias, Cardiac
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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.
David Burke, PhD principal investigator
Beacon Hospital Research Institute, Dublin
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 Arrhythmias, Cardiac, run by PulseAI Ltd at 1 site in Ireland.
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 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: status not confirmed, as of the sponsor's last update on 29 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alan Kennedy, PhD (07714640144, alan.kennedy@pulseai.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the performance of arrhythmia detection. (time frame: 12 months). 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 29 Dec 2022.