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.
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.
Adverse reaction to Skiin garments (e.g. skin allergy)
Pacemaker and/or (ICD) implantable cardioverter defibrillator users.
Pregnancy
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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.
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