Burden-Evaluated Active Therapy for AF Using Continuous Wearables BEAT-AF Trial

Обзор

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.

Вмешательства

• Поведенческое 5D-AF Burden-Guided Active Management
  Continuous PPG-based AF monitoring; Threshold-triggered intervention; Stepwise rhythm control strategy; Antiarrhythmic drug optimization; Catheter ablation evaluation; Anticoagulation management; Comorbidity management; Digital follow-up and education;

Первичные конечные точки

• At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint. [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Patient-reported outcomes [Срок оценки: 24 months]
• Endpoint of effectiveness of atrial fibrillation stress control [Срок оценки: 24 months]
• clinical endpoint [Срок оценки: 24 months]
• Patient-reported outcomes [Срок оценки: 24 months]
• Patient-reported outcomes [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sixth Medical Center of Chinese PLA General Hospital — Пекин

Публикации

• Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x. PMID 15842354
• Przyklenk K, Li G, Whittaker P. No loss in the in vivo efficacy of ischemic preconditioning in middle-aged and old rabbits. J Am Coll Cardiol. 2001 Nov 15;38(6):1741-7. doi: 10.1016/s0735-1097(01)01603-5. PMID 11704390
• Guo Y, Wang H, Wang H, Zhang H, Jin Z. Beyond burden metrics: Wearable photoplethysmography-derived spatiotemporal progression of atrial fibrillation linked to clinical outcomes. Heart Rhythm O2. 2026 Jan 8;7(3):535-544. doi: 10.1016/j.hroo.2025.12.020. eCollection 2026 Mar. PMID 41908207
• Wang H, Liu B, Zhang H, Zhang Z, Jin Z, Wang H, Guo YT. Photoplethysmography-Based Machine Learning Approaches for Atrial Fibrillation Burden: Algorithm Development and Validation. JMIR Cardio. 2025 Nov 10;9:e78075. doi: 10.2196/78075. PMID 41213119
• Becher N, Metzner A, Toennis T, Kirchhof P, Schnabel RB. Atrial fibrillation burden: a new outcome predictor and therapeutic target. Eur Heart J. 2024 Aug 16;45(31):2824-2838. doi: 10.1093/eurheartj/ehae373. PMID 38953776
• Lin M, Liang H, Zhang K, Chen T, Wang J, Han W, Rong B, Zhong J. Optimal timing for atrial fibrillation patients to undergo catheter ablation. Commun Med (Lond). 2025 Jun 22;5(1):245. doi: 10.1038/s43856-025-00960-1. PMID 40544216

Идентификаторы

NCT: NCT07512037 · S2026-023-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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