Atrial FibrillationNCT05161065
Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG
An observational study of Atrial Fibrillation, run by Cardiologs Technologies at 1 site in United States.
Trial summary
The WatchQT study will compare the performance of a smartwatch combined with Cardiologs ECG AI Analysis system in monitoring corrected QT (QTc) intervals with that measured on a manually read 12-lead ECG in subjects with Normal Sinus Rhythm (NSR) during antiarrhythmic drug (AAD) initiation and follow-up at the… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiologs
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2022to 28 Feb 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 to 50 Subjects: Subjects who are being hospitalized for antiarrhythmic drug (AAD) initiation and monitoring per standard of care.
Who may be able to join
- Subjects over 22, able and willing to participate in the study
- Subjects who are admitted to the hospital in NSR or AF and are eligible for AAD (class Ia or class III) dose initiation or re-initiation.
- 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 Cardiac Implantable Electronic Devices (CIED)
- Pregnant or breast-feeding subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG in Subjects Hospitalized for Antiarrhythmic Drug Initiation and Follow-up
The WatchQT study will compare the performance of a smartwatch combined with Cardiologs ECG AI Analysis system in monitoring corrected QT (QTc) intervals with that measured on a manually read 12-lead ECG in subjects with Normal Sinus Rhythm (NSR) during antiarrhythmic drug (AAD) initiation and follow-up at the hospital.
Read the detailed description
The WatchQT Study is a prospective, non-significant risk, non-randomized, monocentric, open, comparative, concordance pilot study.
Under subject consent, subjects hospitalized for AAD initiation and monitoring will have smartwatch ECG recordings done simultaneously with 12-lead ECG measurements before and after drug administration twice a day, in accordance with the existing in-stay subject monitoring protocol.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiologs
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiologsDevice
Also called Apple Watch
Apple Watch 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.
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
Concordance between QTc intervals measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG for each measurement done during NSR. The Bazett (QTcB in ms) and Fridericia (QTcF in ms) methods will be used to correct QT intervals
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Secondary outcomes (7)
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI in determining subjects at risk of AAD induced ventricular arrhythmia compared to that identified by manually read 12-lead ECG in subjects with a prolonged QTc > 500 ms and/or subjects with a QTc prolongation of > 15% after their initial AAD dose
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Concordance between QTcB and QTcF intervals measured by the different methods
Concordance between QTcB and QTcF intervals measured by the different methods (smartwatch combined with Cardiologs AI, smartwatch read manually, 12-lead read manually, lead 1 from 12-lead read manually and automated interpretation of the 12 lead ECG machine)
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Description of the QTc interval measurements in NSR
Description of the QTc interval measurements in NSR as a function of timepoints by the different methods
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Quantitative analysis to determine the interobserver variability
Quantitative analysis to determine the interobserver variability in QTc interval measurements by the smartwatch and 12-lead ECG manual readings
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG
.Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG at each timepoint and overall.
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Analysis of QT interval measured in subsets of subjects with and without wide QRS
Patient with wide QRS is determined as a QRS>120ms at D0 from automated interpretation of the 12-lead ECG machine. The analysis will be done in subset of 2 groups according to the QRS measured as wide or not machine
Measured: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start12 Feb 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiologs Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jagmeet Singh, MD ScM DPhil, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161065
- Sponsor's protocol ID
- WatchQT
- Status last verified
- Oct 2023
- First submitted
- 22 Nov 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
- Comparison of QT Interval Readings Between Smartwatch Combined With Cardiologs Artificial Intelligence and 12-lead ECG in Subjects Hospitalized for Antiarrhythmic Drug Initiation and Follow-up
- ClinicalTrials.gov ID
- NCT05161065
- Acronym / sponsor ID
- WatchQT
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cardiologs TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 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 WatchQT study will compare the performance of a smartwatch combined with Cardiologs ECG AI Analysis system in monitoring corrected QT (QTc) intervals with that measured on a manually read 12-lead ECG in subjects with Normal Sinus Rhythm (NSR) during antiarrhythmic drug (AAD) initiation and follow-up at the hospital.
Detailed description
The WatchQT Study is a prospective, non-significant risk, non-randomized, monocentric, open, comparative, concordance pilot study.
Under subject consent, subjects hospitalized for AAD initiation and monitoring will have smartwatch ECG recordings done simultaneously with 12-lead ECG measurements before and after drug administration twice a day, in accordance with the existing in-stay subject monitoring protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 to 50 Subjects: Subjects who are being hospitalized for antiarrhythmic drug (AAD) initiation and monitoring per standard of care.
Key inclusion criteria (3 listed)
- Subjects over 22, able and willing to participate in the study
- Subjects who are admitted to the hospital in NSR or AF and are eligible for AAD (class Ia or class III) dose initiation or re-initiation.
- 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 Cardiac Implantable Electronic Devices (CIED)
- 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 |
|---|---|---|
| CardiologsAlso: Apple WatchApple Watch recordings interpreted by Cardiologs AI done simultaneously with each 12-lead ECG | Device | – |
Primary outcome
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Concordance between QTc intervals measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG for each measurement done during NSR. The Bazett (QTcB in ms) and Fridericia (QTcF in ms) methods will be used to correct QT intervals
7 secondary outcomes
Description of the sensitivity and specificity of the smartwatch combined with Cardiologs AI
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Concordance between QTcB and QTcF intervals measured by the different methods
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Description of the QTc interval measurements in NSR
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Quantitative analysis to determine the interobserver variability
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Description of the QT interval defined as uncertain by the smartwatch combined with Cardiologs AI
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Descriptive analysis of QT interval measurements in AF measured by smartwatch combined with Cardiologs AI and manually read 12-lead ECG
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
Analysis of QT interval measured in subsets of subjects with and without wide QRS
Time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization
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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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.
Jagmeet Singh, MD ScM DPhil principal investigator
Massachusetts General Hospital
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 Atrial Fibrillation, run by Cardiologs Technologies 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 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 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?
Concordance between QTc intervals (in ms) measured by smartwatch combined with Cardiologs AI and that measured by manually read 12-lead ECG (time frame: Readings taken simultaneously right before and 2-3 hours after drug administration during hospitalization). 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.