Atrial Fibrillation (AF), Digital Health Intervention, Wearable Monitoring
Conditions
Keywords
Atrial Fibrillation, AF Burden, Wearable Devices, Photoplethysmography (PPG), Digital Health, Early Intervention
Brief summary
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.
Interventions
BEHAVIORAL5D-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;
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. If anticoagulation therapy is being administered, the treatment plan must be stable for at least 4 weeks; 2. If heart rate or rhythm control medications are being used, the treatment plan must be stable for at least 4 weeks; 3. Or no specific rhythm control treatment for atrial fibrillation is being received; * Sign the informed consent form
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcomes | 24 months | Atrial fibrillation symptoms (EHRA symptom score) |
| Endpoint of effectiveness of atrial fibrillation stress control | 24 months | The overall load of 5D-AF at the assessment time point \< 4.59% |
| clinical endpoint | 24 months | Atrial fibrillation progression, heart failure, stroke, systemic embolism, transient ischemic attack, venous thromboembolism, cardiovascular-related hospitalization, all-cause hospitalization, cardiovascular-related mortality, all-cause mortality, bleeding events, and the rate of catheter ablation treatment for atrial |
Countries
China
Contacts
CONTACTJIN ZHI-GENG, Doctor
CONTACTYU-TAO GUO, Doctor, Study Chair
Outcome results
None listed