Atrial FibrillationWEAR-AFNCT06564012
Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
An observational study of Atrial Fibrillation and Arrhythmias, Cardiac, run by Sunnybrook Health Sciences Centre.
Trial summary
The WEAR-AF study is a prospective, multicenter clinical trial designed to evaluate the efficacy of wearable technology in the detection, monitoring, and management of atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: The study population includes adult patients diagnosed with atrial fibrillation (AF) who are scheduled to undergo catheter ablation. Participants must have a history of symptomatic AF and be deemed appropriate candidates for ablation by their healthcare provider. The study focuses on evaluating the use of wearable cardiac monitoring devices post-ablation, with participants being monitored for a period of 6 months to assess various outcomes related to AF recurrence, device compliance, and patient satisfaction.
Who may be able to join
- Adults aged 18 years or older.
- Diagnosed with paroxysmal or persistent atrial fibrillation.
- Scheduled to undergo catheter ablation for atrial fibrillation.
- Able to provide informed consent.
- Willing to wear the Skiin garments (chest band or bralette) for the duration of the study (approximately 1 month pre and 6 months post-ablation).
- Have a smartphone with an Operating System compatible with the Skiin Connected Life App (Android 9+ or iOS 13+)
Who cannot join
- Adverse reaction to Skiin garments (e.g. skin allergy)
- The relevant Skiin Underwear contraindications acting as exclusion criteria for this study are:
- Pacemaker and/or (ICD) implantable cardioverter defibrillator users.
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The WEAR-AF study is a prospective, multicenter clinical trial designed to evaluate the efficacy of wearable technology in the detection, monitoring, and management of atrial fibrillation (AF). This study aims to assess how wearable devices, such as smartwatches equipped with electrocardiogram (ECG) capabilities, can be used to identify AF episodes, guide treatment decisions, and ultimately improve patient outcomes.
Participants will be individuals diagnosed with or at high risk for atrial fibrillation. The study will track the accuracy of AF detection, patient adherence to monitoring, and the impact on clinical outcomes, including stroke prevention, symptom management, and quality of life.
The findings from WEAR-AF are expected to contribute to the growing body of evidence supporting the integration of wearable technology into routine clinical practice for AF management, offering insights into its potential to enhance patient care and reduce healthcare costs.
Read the detailed description
Study Description:
The WEAR-AF study is a prospective, multicenter clinical trial designed to evaluate the effectiveness and clinical utility of wearable technology in the detection, monitoring, and management of atrial fibrillation (AF). This study seeks to understand how wearable devices, particularly those with electrocardiogram (ECG) capabilities, can be integrated into routine clinical practice to enhance the early detection and continuous monitoring of AF, a common and potentially serious cardiac arrhythmia.
Background and Rationale:
Atrial fibrillation is a significant public health issue, associated with increased risks of stroke, heart failure, and other cardiovascular complications. Current guidelines emphasize the importance of early detection and continuous monitoring of AF to manage symptoms and prevent complications effectively. Wearable technology, such as smartwatches and fitness trackers equipped with ECG functions, has emerged as a promising tool for real-time AF detection and monitoring. However, the clinical efficacy, accuracy, and patient adherence associated with these devices require further investigation.
Objectives:
The primary objective of the WEAR-AF study is to evaluate the diagnostic accuracy of wearable ECG devices in detecting AF episodes compared to standard clinical practices, such as Holter monitoring and traditional ECGs. Secondary objectives include assessing the impact of continuous AF monitoring on clinical outcomes, including stroke prevention, symptom management, and patient quality of life. The study will also examine patient adherence to the use of wearable technology and its influence on healthcare utilization and costs.
Study Design:
WEAR-AF is a prospective, observational study that will enroll participants across multiple centers. Eligible participants include individuals diagnosed with AF or those at high risk for developing AF. Participants will be provided with wearable devices equipped with ECG capabilities and will be monitored over a specified period. The study will compare the AF detection rates of these wearable devices against standard diagnostic tools, evaluate the consistency of AF management with the wearable devices' data, and document any changes in clinical outcomes over time.
Endpoints:
Primary Endpoint:
Diagnostic accuracy of wearable ECG devices in detecting AF compared to standard methods.
Secondary Endpoints:
Impact of wearable ECG monitoring on stroke incidence and other cardiovascular events.
Changes in AF-related symptoms and quality of life as measured by validated questionnaires.
Patient adherence to the use of wearable technology for continuous AF monitoring.
Healthcare utilization and cost-effectiveness analysis.
Significance:
The WEAR-AF study aims to generate robust evidence on the role of wearable technology in managing AF. By providing insights into the accuracy, utility, and patient adherence to these devices, the study will contribute to the development of guidelines for the integration of wearable technology into clinical practice. The ultimate goal is to improve patient outcomes by enabling more timely and precise management of AF.
Conclusion:
The WEAR-AF study will explore the potential of wearable technology to transform the management of atrial fibrillation. Through this research, we aim to provide valuable data on the effectiveness of wearable ECG devices in real-world settings, offering a foundation for future innovations in digital health and personalized medicine.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Stroke Prevention
- Keywords
- digital health, wearable technology, electrocardiography, remote monitoring, patient adherence
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Atrial Tachyarrhythmia Recurrence
The primary outcome measure is the incidence of any atrial tachyarrhythmia lasting 30 seconds or longer, as detected by continuous monitoring with Skiin garments within 6 months following catheter ablation for atrial fibrillation. The occurrence of these arrhythmias will be tracked to assess the efficacy of the wearable device in detecting recurrences during the post-ablation period.
Measured: 6 months post-ablation
Secondary outcomes (4)
Compliance with Wearable Cardiac Monitoring Device
The measure of compliance will assess the proportion of time participants adhere to wearing the Skiin garments as prescribed over a 6-month period post-ablation. Compliance will be evaluated through data logs recorded by the wearable device, providing insights into participant engagement and adherence to the monitoring protocol.
Measured: 6 months post-ablation
Patient Satisfaction with Wearable Cardiac Monitoring Device
This outcome will evaluate patient satisfaction with the Skiin wearable cardiac monitoring device compared to traditional intermittent 14-day cardiac monitoring. Satisfaction will be measured using a validated questionnaire administered to participants at the end of the 6-month monitoring period, capturing feedback on comfort, ease of use, and overall experience with the wearable device.
Measured: At the end of the 6-month monitoring period
Impact on Quality of Life
The impact of continuous wearable cardiac monitoring on the overall quality of life of participants post-ablation will be assessed. Quality of life will be measured using a validated tool such as the SF-36 or EQ-5D-5L at baseline and at the end of the 6-month monitoring period, with comparisons made to baseline measures and intermittent monitoring.
Measured: Baseline and 6 months post-ablation
Time to First Recurrence of Atrial Tachyarrhythmia
The time to the first documented recurrence of atrial tachyarrhythmia during continuous monitoring with Skiin garments post-ablation will be assessed. This outcome will provide insights into the efficacy of continuous monitoring in detecting arrhythmia recurrence earlier compared to traditional intermittent monitoring methods.
Measured: From the time of ablation to the first documented recurrence within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completionDec 2026 (estimated)
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.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Cheung, MD, Principal investigator, Sunnybrook Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564012
- Sponsor's protocol ID
- 4513
- Acronym
- WEAR-AF
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06564012
- Acronym / sponsor ID
- WEAR-AF / 4513
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Stroke Prevention
- Keywords
- digital health, wearable technology, electrocardiography, remote monitoring, patient adherence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (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 WEAR-AF study is a prospective, multicenter clinical trial designed to evaluate the efficacy of wearable technology in the detection, monitoring, and management of atrial fibrillation (AF). This study aims to assess how wearable devices, such as smartwatches equipped with electrocardiogram (ECG) capabilities, can be used to identify AF episodes, guide treatment decisions, and ultimately improve patient outcomes.
Participants will be individuals diagnosed with or at high risk for atrial fibrillation. The study will track the accuracy of AF detection, patient adherence to monitoring, and the impact on clinical outcomes, including stroke prevention, symptom management, and quality of life.
The findings from WEAR-AF are expected to contribute to the growing body of evidence supporting the integration of wearable technology into routine clinical practice for AF management, offering insights into its potential to enhance patient care and reduce healthcare costs.
Detailed description
Study Description:
The WEAR-AF study is a prospective, multicenter clinical trial designed to evaluate the effectiveness and clinical utility of wearable technology in the detection, monitoring, and management of atrial fibrillation (AF). This study seeks to understand how wearable devices, particularly those with electrocardiogram (ECG) capabilities, can be integrated into routine clinical practice to enhance the early detection and continuous monitoring of AF, a common and potentially serious cardiac arrhythmia.
Background and Rationale:
Atrial fibrillation is a significant public health issue, associated with increased risks of stroke, heart failure, and other cardiovascular complications. Current guidelines emphasize the importance of early detection and continuous monitoring of AF to manage symptoms and prevent complications effectively. Wearable technology, such as smartwatches and fitness trackers equipped with ECG functions, has emerged as a promising tool for real-time AF detection and monitoring. However, the clinical efficacy, accuracy, and patient adherence associated with these devices require further investigation.
Objectives:
The primary objective of the WEAR-AF study is to evaluate the diagnostic accuracy of wearable ECG devices in detecting AF episodes compared to standard clinical practices, such as Holter monitoring and traditional ECGs. Secondary objectives include assessing the impact of continuous AF monitoring on clinical outcomes, including stroke prevention, symptom management, and patient quality of life. The study will also examine patient adherence to the use of wearable technology and its influence on healthcare utilization and costs.
Study Design:
WEAR-AF is a prospective, observational study that will enroll participants across multiple centers. Eligible participants include individuals diagnosed with AF or those at high risk for developing AF. Participants will be provided with wearable devices equipped with ECG capabilities and will be monitored over a specified period. The study will compare the AF detection rates of these wearable devices against standard diagnostic tools, evaluate the consistency of AF management with the wearable devices' data, and document any changes in clinical outcomes over time.
Endpoints:
Primary Endpoint:
Diagnostic accuracy of wearable ECG devices in detecting AF compared to standard methods.
Secondary Endpoints:
Impact of wearable ECG monitoring on stroke incidence and other cardiovascular events.
Changes in AF-related symptoms and quality of life as measured by validated questionnaires.
Patient adherence to the use of wearable technology for continuous AF monitoring.
Healthcare utilization and cost-effectiveness analysis.
Significance:
The WEAR-AF study aims to generate robust evidence on the role of wearable technology in managing AF. By providing insights into the accuracy, utility, and patient adherence to these devices, the study will contribute to the development of guidelines for the integration of wearable technology into clinical practice. The ultimate goal is to improve patient outcomes by enabling more timely and precise management of AF.
Conclusion:
The WEAR-AF study will explore the potential of wearable technology to transform the management of atrial fibrillation. Through this research, we aim to provide valuable data on the effectiveness of wearable ECG devices in real-world settings, offering a foundation for future innovations in digital health and personalized medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients diagnosed with atrial fibrillation (AF) who are scheduled to undergo catheter ablation. Participants must have a history of symptomatic AF and be deemed appropriate candidates for ablation by their healthcare provider. The study focuses on evaluating the use of wearable cardiac monitoring devices post-ablation, with participants being monitored for a period of 6 months to assess various outcomes related to AF recurrence, device compliance, and patient satisfaction.
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Diagnosed with paroxysmal or persistent atrial fibrillation.
- Scheduled to undergo catheter ablation for atrial fibrillation.
- Able to provide informed consent.
- Willing to wear the Skiin garments (chest band or bralette) for the duration of the study (approximately 1 month pre and 6 months post-ablation).
Key exclusion criteria (4 listed)
- Adverse reaction to Skiin garments (e.g. skin allergy)
- The relevant Skiin Underwear contraindications acting as exclusion criteria for this study are:
- Pacemaker and/or (ICD) implantable cardioverter defibrillator users.
- Pregnancy
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
Incidence of Atrial Tachyarrhythmia Recurrence
Time frame: 6 months post-ablation
The primary outcome measure is the incidence of any atrial tachyarrhythmia lasting 30 seconds or longer, as detected by continuous monitoring with Skiin garments within 6 months following catheter ablation for atrial fibrillation. The occurrence of these arrhythmias will be tracked to assess the efficacy of the wearable device in detecting recurrences during the post-ablation period.
4 secondary outcomes
Compliance with Wearable Cardiac Monitoring Device
Time frame: 6 months post-ablation
Patient Satisfaction with Wearable Cardiac Monitoring Device
Time frame: At the end of the 6-month monitoring period
Impact on Quality of Life
Time frame: Baseline and 6 months post-ablation
Time to First Recurrence of Atrial Tachyarrhythmia
Time frame: From the time of ablation to the first documented recurrence within 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Related trials for Atrial Fibrillation
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
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Christopher Cheung, MD principal investigator
Sunnybrook Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Arrhythmias, Cardiac, run by Sunnybrook Health Sciences Centre.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aditi Garg, MA (5196612111 ext. 86013, aditi.garg@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Atrial Tachyarrhythmia Recurrence (time frame: 6 months post-ablation). 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 25 May 2025.