Atrial Fibrillation (AF)NCT07512037
Burden-Evaluated Active Therapy for AF Using Continuous Wearables BEAT-AF Trial
A study testing 5D-AF Burden-Guided Active Management in people with Atrial Fibrillation (AF) and Digital Health Intervention, run by Navy General Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Digital Health Intervention, Wearable Monitoring
- What is being tested?
- 5D-AF Burden-Guided Active Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,194 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sixth Medical Center of Chinese PLA General Hospital
Beijing
JIN ZHI-GENG, Doctor, 8615801402223, lwgjzg@163.com
About this study
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.
- Being tested
- 5D-AF Burden-Guided Active Management
- Keywords
- Atrial Fibrillation, AF Burden, Wearable Devices, Photoplethysmography (PPG), Digital Health, Early Intervention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5D-AF Burden-Guided Active ManagementBehavioural
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;
| Study group | Role | What they receive |
|---|---|---|
| 5D-AF Burden-Guided Active Management | Experimental | Participants will receive wearable-based AF burden monitoring with treatment decisions guided by a predefined AF burden threshold (≥4.59%). Receives: Behavioral: 5D-AF Burden-Guided Active Management |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Patient-reported outcomes
Atrial fibrillation symptoms (EHRA symptom score)
Measured: 24 months
Endpoint of effectiveness of atrial fibrillation stress control
The overall load of 5D-AF at the assessment time point < 4.59%
Measured: 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
Measured: 24 months
Patient-reported outcomes
quality of life score(EQ-5D-5L)
Measured: 24 months
Patient-reported outcomes
cognitive function changes (MoCA score)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512037
- Sponsor's protocol ID
- S2026-023-01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15842354Przyklenk 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.
PubMed 11704390Guo 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.
PubMed 41908207Wang 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.
PubMed 41213119Becher 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.
PubMed 38953776Lin 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.
PubMed 40544216
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden-Evaluated Active Therapy for AF Using Continuous Wearables BEAT-AF Trial
- ClinicalTrials.gov ID
- NCT07512037
- Acronym / sponsor ID
- S2026-023-01
- Keywords
- Atrial Fibrillation, AF Burden, Wearable Devices, Photoplethysmography (PPG), Digital Health, Early Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,194 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5D-AF Burden-Guided Active Management | Experimental | Behavioral: 5D-AF Burden-Guided Active ManagementParticipants will receive wearable-based AF burden monitoring with treatment decisions guided by a predefined AF burden threshold (≥4.59%). |
| Usual Care | No intervention | –Participants will receive guideline-directed standard care without AF burden-guided intervention. Routine follow-up; Standard medical therapy; Physician-directed rhythm/rate control; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5D-AF Burden-Guided Active ManagementContinuous 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; | Behavioural | 5D-AF Burden-Guided Active Management |
Primary outcome
At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint.
Time frame: 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.
5 secondary outcomes
Patient-reported outcomes
Time frame: 24 months
Endpoint of effectiveness of atrial fibrillation stress control
Time frame: 24 months
clinical endpoint
Time frame: 24 months
Patient-reported outcomes
Time frame: 24 months
Patient-reported outcomes
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 15842354Schulman 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.
- Background: PubMed 11704390Przyklenk 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.
- Background: PubMed 41908207Guo 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.
- Background: PubMed 41213119Wang 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.
- Background: PubMed 38953776Becher 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.
- Background: PubMed 40544216Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5D-AF Burden-Guided Active Management in people with Atrial Fibrillation (AF) and Digital Health Intervention, run by Navy General Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIN ZHI-GENG, Doctor (86+15801402223, lwgjzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At the 12-month follow-up, the time until the occurrence of the first AF-related composite adverse event endpoint. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512037, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.