Burden-Evaluated Active Therapy for AF Using Continuous Wearables BEAT-AF Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,194
- 试验地点
- 1
- 主要终点
- At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint.
研究概览
简要总结
Traditional AF classification (e.g., paroxysmal, persistent, permanent) relies largely on patient-reported symptoms and intermittent electrocardiographic monitoring, which cannot continuously or objectively reflect disease progression, nor effectively inform optimal intervention timing. Although "AF burden" (i.e., duration of AF episodes) has emerged as a potential marker, its association with clinical outcomes remains inconsistent due to limitations in monitoring methods and its one-dimensional nature. Based on our previous work, investigators developed a five-dimensional AF progression model using photoplethysmography (PPG) signals collected from wearable devices. This model quantifies AF progression across five domains: episode frequency, duration, temporal aggregation, circadian rhythm, and tachycardia burden, enabling continuous and multidimensional assessment. Prior validation has demonstrated high agreement with 24-hour Holter monitoring and effective identification of high-risk patients.
The BEAT-AF trial is designed to evaluate the clinical utility of this model in a real-world setting. Specifically, investigators will investigate whether early intervention (e.g., optimization of medical therapy or consideration of catheter ablation) in patients with elevated five-dimensional AF burden (≥4.59%) can reduce symptoms, rhythm/rate-related abnormalities, and AF-related adverse events (such as stroke and heart failure). This study is expected to provide new evidence for dynamic monitoring of AF progression, optimal timing of intervention, and personalized management strategies, ultimately improving patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Inpatients ≥18 years of age at admission;
- •Paroxysmal atrial fibrillation was diagnosed;
- •Own a smart phone and a smart watch and be able to operate them basically;
- •Before being enrolled, the average daily atrial fibrillation burden was calculated to be ≥ 4.59% based on monitoring through an intelligent wristwatch for at least 3 days;
- •The treatment status meets any of the following conditions:
- •If anticoagulation therapy is being administered, the treatment plan must be stable for at least 4 weeks;
- •If heart rate or rhythm control medications are being used, the treatment plan must be stable for at least 4 weeks;
- •Or no specific rhythm control treatment for atrial fibrillation is being received;
- •Sign the informed consent form
排除标准
- •Has an implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device.
- •There may be skin diseases, limb deformities or allergies that prevent the proper wearing of wearable devices on the upper limbs.
- •Having active mental disorders or cognitive impairments, as well as other conditions that result in lack of or restricted ability to act, and which, in the judgment of the researchers, make it impossible for the subject to comply with the trial protocol.
- •During pregnancy, lactation, or planning to become pregnant during the trial period.
- •At the same time, participate in other clinical trials that may interfere with the results of this study
研究组 & 干预措施
5D-AF Burden-Guided Active Management
Participants will receive wearable-based AF burden monitoring with treatment decisions guided by a predefined AF burden threshold (≥4.59%).
干预措施: 5D-AF Burden-Guided Active Management (Behavioral)
Usual Care
Participants will receive guideline-directed standard care without AF burden-guided intervention. Routine follow-up; Standard medical therapy; Physician-directed rhythm/rate control;
结局指标
主要结局
At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint.
时间窗: 12 months
The occurrence of the AF-related composite adverse event endpoint, which consists of any of the following events: progression of atrial fibrillation, heart failure, stroke, systemic embolism, and cardiovascular-related hospitalization.
次要结局
- Patient-reported outcomes(24 months)
- Endpoint of effectiveness of atrial fibrillation stress control(24 months)
- clinical endpoint(24 months)