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

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF); Digital Health Intervention; Wearable Monitoring
• Intervention / Treatment: Behavioral: 5D-AF Burden-Guided Active Management

• Study Type: Interventional
• Enrollment (Estimated): 3194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JIN ZHI-GENG, Doctor; Phone Number: 86+15801402223; Email: lwgjzg@163.com
• Study Contact Backup: Name: YU-TAO GUO, Doctor, Study Chair; Phone Number: 86+13810021492; Email: dor_guoyt@hotmail.com

Study Locations

• China
  • Beijing, China
    • Sixth Medical Center of Chinese PLA General Hospital
    • Contact: JIN ZHI-GENG, Doctor; Phone Number: 8615801402223; Email: lwgjzg@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%).	Behavioral: 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;
No Intervention: 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcomes	Atrial fibrillation symptoms (EHRA symptom score)	24 months
Endpoint of effectiveness of atrial fibrillation stress control	The overall load of 5D-AF at the assessment time point < 4.59%	24 months
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	24 months
Patient-reported outcomes	quality of life score(EQ-5D-5L)	24 months
Patient-reported outcomes	cognitive function changes (MoCA score)	24 months

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing

Publications and helpful links

General Publications

• 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.
• 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.
• 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), https://doi.org/10.1016/j.hroo.2025.12.020.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Digital Health; Early Intervention; AF Burden; Photoplethysmography (PPG); Wearable Devices
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: S2026-023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No