Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation

NCT06564012 | Not Yet Recruiting

• 1 other identifier: 4513
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Stroke Prevention

Keywords

digital health; wearable technology; electrocardiography; remote monitoring; patient adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months post-ablation

Secondary Outcomes (4)

• Compliance with Wearable Cardiac Monitoring Device

  6 months post-ablation

• Patient Satisfaction with Wearable Cardiac Monitoring Device

  At the end of the 6-month monitoring period

• Impact on Quality of Life

  Baseline and 6 months post-ablation

• Time to First Recurrence of Atrial Tachyarrhythmia

  From the time of ablation to the first documented recurrence within 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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+)

You may not qualify if:

• Adverse reaction to Skiin garments (e.g. skin allergy)
• Pacemaker and/or (ICD) implantable cardioverter defibrillator users.
• Pregnancy

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Patient Compliance

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christopher Cheung, MD

  Sunnybrook Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aditi Garg, MA

CONTACT

5196612111; aditi.garg@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2024-08