Wearable Cardiac Monitor to Enhance Detection of Arrhythmia Recurrence After Catheter Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Incidence of Atrial Tachyarrhythmia Recurrence
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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+)
排除标准
- •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
结局指标
主要结局
Incidence of Atrial Tachyarrhythmia Recurrence
时间窗: 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.
次要结局
- Patient Satisfaction with Wearable Cardiac Monitoring Device(At the end of the 6-month monitoring period)
- Compliance with Wearable Cardiac Monitoring Device(6 months post-ablation)
- 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)