Atrial FibrillationNCT05167058
Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
An observational study of Atrial Fibrillation and Tachycardia, run by Cardiologs Technologies at 3 sites in United States.
Trial summary
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Tachycardia, Bradycardia
- What is being tested?
- Cardiologs Platform
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2022to 31 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 subjects: subjects who are hospitalized for cardioversion or AF ablation procedure per standard of care
Who may be able to join
- Subjects over 18, able and willing to participate in the study
- Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
- Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted
Who cannot join
- Subjects with paced rhythm or implanted electronic devices
- Pregnant or breast-feeding subjects
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hackensack Meridian School of Medicine
Hackensack, New Jersey, 07601
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, 10032
The Valley Hospital
Ridgewood, New Jersey, 07450
About this study
Official title: Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.
Read the detailed description
The SWAF study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study.
Under subject consent, subjects hospitalized for cardioversion or AF ablation will have a smartwatch ECG recording done simultaneously with 12-lead ECG measurement right before the intervention. If a subject is found in Normal Sinus Rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. All the measurements will be done in accordance with the existing subject monitoring protocol.
- Conditions
- Atrial Fibrillation, Tachycardia, Bradycardia, Premature Supraventricular Beat, Premature Ventricular Contraction
- Being tested
- Cardiologs Platform
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Bradycardia, Atrial Premature Complexes, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiologs PlatformDevice
Also called Smartwatch
Smartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG in the independent annotation center, providing the ground truth from the 12-lead ECG
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary outcomes (7)
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Sinus Rhythm as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Sinus Rhythm as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Ventricular Complexes as identified by the physician on the smartwatch ECG
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Ventricular Complexes as identified by the physician on the smartwatch ECG in the independent annotation center, providing the ground truth from the smartwatch ECG.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician
Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician. Inconclusive may mean that there may have been too much artefact or noise to acquire a good signal or that the rhythm is unclassifiable or contains other abnormal rhythm.
Measured: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start21 Apr 2022
- Primary completion20 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiologs Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elaine Y Wan, MD, Principal investigator, Columbia University, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167058
- Sponsor's protocol ID
- SWAF
- Status last verified
- Oct 2023
- First submitted
- 8 Dec 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
- ClinicalTrials.gov ID
- NCT05167058
- Acronym / sponsor ID
- SWAF
- Conditions
- Atrial Fibrillation, Tachycardia, Bradycardia, Premature Supraventricular Beat, Premature Ventricular Contraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Cardiologs TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Dec 2021 (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 SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.
Detailed description
The SWAF study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study.
Under subject consent, subjects hospitalized for cardioversion or AF ablation will have a smartwatch ECG recording done simultaneously with 12-lead ECG measurement right before the intervention. If a subject is found in Normal Sinus Rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. All the measurements will be done in accordance with the existing subject monitoring protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 subjects: subjects who are hospitalized for cardioversion or AF ablation procedure per standard of care
Key inclusion criteria (3 listed)
- Subjects over 18, able and willing to participate in the study
- Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
- Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted
Key exclusion criteria (2 listed)
- Subjects with paced rhythm or implanted electronic devices
- Pregnant or breast-feeding subjects
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 |
|---|---|---|
| Cardiologs PlatformAlso: SmartwatchSmartwatch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG | Device | – |
Primary outcome
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG in the independent annotation center, providing the ground truth from the 12-lead ECG
7 secondary outcomes
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Sinus Rhythm as identified by the physician on the smartwatch ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Ventricular Complexes as identified by the physician on the smartwatch ECG
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician
Time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
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 3 Oct 2023.
- Individual participant dataSharing planned: No
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
Elaine Y Wan, MD principal investigator
Columbia University, New York
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Tachycardia, run by Cardiologs Technologies at 3 sites 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG (time frame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital). 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 3 Oct 2023.