Clinical trial NCT06564012: Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
Official title: Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Stroke Prevention
Keywords: digital health
wearable technology
electrocardiography
remote monitoring
patient adherence
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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+)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Atrial Tachyarrhythmia Recurrence
timeFrame: 6 months post-ablation
Secondary outcomes:
measure: Compliance with Wearable Cardiac Monitoring Device
timeFrame: 6 months post-ablation
measure: Patient Satisfaction with Wearable Cardiac Monitoring Device
timeFrame: At the end of the 6-month monitoring period
measure: Impact on Quality of Life
timeFrame: Baseline and 6 months post-ablation
measure: Time to First Recurrence of Atrial Tachyarrhythmia
timeFrame: From the time of ablation to the first documented recurrence within 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Hospital
name: Christopher Cheung, MD
role: PRINCIPAL_INVESTIGATOR
References: