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

NCT07512037 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3194

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)
  • Digital Health Intervention
  • Wearable Monitoring

Interventions

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;

Sponsors & Collaborators

  • Navy General Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-06-30
Completion
2029-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512037 on ClinicalTrials.gov