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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNavy General Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5D-AF Burden-Guided Active Management

    Behavioral

    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;

Treatment groups

3,194 Participants
are divided into 2 treatment groups
Group A: 5D-AF Burden-Guided Active ManagementExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint.

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.

Time frame
12 months

Secondary outcomes

1

Patient-reported outcomes

Atrial fibrillation symptoms (EHRA symptom score)

Time frame
24 months
2

Endpoint of effectiveness of atrial fibrillation stress control

The overall load of 5D-AF at the assessment time point \< 4.59%

Time frame
24 months
3

clinical endpoint

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

Time frame
24 months
4

Patient-reported outcomes

quality of life score(EQ-5D-5L)

Time frame
24 months

Other outcomes

Sponsors and contacts

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