Atrial Fibrillation (AF)NCT07497906
Burden-Evaluated Atrial Fibrillation Progession and ThromboEmbolim Study BEAT-AF TE Study
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation Burden, run by Navy General Hospital, Beijing.
Trial summary
This was a prospective, multicenter, observational cohort study. Patients with atrial fibrillation were consecutively recruited from the Cardiovascular Research Platform. After providing written informed consent, research assistants scheduled and assigned the patients to the participating centers of the BEAT-AF TE… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation Burden
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- Adult, Older adult
Study population: This was a prospective, multicenter, observational cohort study of adult patients with a confirmed diagnosis of atrial fibrillation. Patients meeting the inclusion and exclusion criteria were planned to be consecutively recruited through the Cardiovascular Research Platform, with an expected total sample size of 10,000 patients and an estimated screening pool of approximately 670,000 patients. The patients were enrolled from 55 research centers across the country, covering multiple geographic regions. All enrolled patients will undergo a 24-month follow-up period, with follow-up visits scheduled at 3, 6, 12, and 24 months after enrollment. No additional interventions were applied in this study; patient management was based on local clinical practice. The primary exposure variable was the five-dimensional atrial fibrillation burden indicator, and the primary outcome was the first occurrence of ischemic stroke or systemic embolism within 12 months.
Who may be able to join
- (1) age ≥ 18 years; (2) confirmed diagnosis of atrial fibrillation (paroxysmal, persistent, or permanent); (3) ownership of a smartphone and a smartwatch, with the ability to perform basic operations; (4) provision of electronic informed consent.
Who cannot join
- (1) presence of clear indications for anticoagulation therapy (e.g., mechanical heart valve, recent venous thromboembolism); (2) life expectancy < 1 year; (3) severe cognitive impairment or psychiatric disorder; (4) known allergy to materials used in wearable devices; (5) concurrent participation in another clinical trial that may interfere with the outcomes of this study; (6) presence of an implanted pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device; (7) pregnancy, lactation, or planned pregnancy during the study period.
About this study
This was a prospective, multicenter, observational cohort study. Patients with atrial fibrillation were consecutively recruited from the Cardiovascular Research Platform. After providing written informed consent, research assistants scheduled and assigned the patients to the participating centers of the BEAT-AF TE project according to their individual circumstances. Each center conducted follow-up management in accordance with the investigator's handbook, with a follow-up duration of 24 months. The patients were managed according to local clinical practice, and no study-related interventions were administered in this study; only follow-up data were recorded. This real-world data analysis aimed to investigate, based on the primary exposure variable (atrial fibrillation burden), primary outcome variables (ischemic stroke, systemic embolism, etc.), and secondary outcome variables (transient ischemic attack, hospitalization for heart failure, major bleeding events, all-cause mortality, etc.), whether there is a risk inflection point between atrial fibrillation burden and stroke, whether there is a reasonable threshold for the benefit of anticoagulation therapy, and whether there is a time-dependent risk of atrial fibrillation burden prior to stroke/thromboembolic events.
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of the composite endpoint of clinical embolic events at 12 months of follow-up. The endpoint comprised any of the following events: ischemic stroke or systemic embolism.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 12 Months
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
- NCT07497906
- Sponsor's protocol ID
- S2026-022-01
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden-Evaluated Atrial Fibrillation Progession and ThromboEmbolim Study BEAT-AF TE Study
- ClinicalTrials.gov ID
- NCT07497906
- Acronym / sponsor ID
- S2026-022-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 27 Mar 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.
This was a prospective, multicenter, observational cohort study. Patients with atrial fibrillation were consecutively recruited from the Cardiovascular Research Platform. After providing written informed consent, research assistants scheduled and assigned the patients to the participating centers of the BEAT-AF TE project according to their individual circumstances. Each center conducted follow-up management in accordance with the investigator's handbook, with a follow-up duration of 24 months. The patients were managed according to local clinical practice, and no study-related interventions were administered in this study; only follow-up data were recorded. This real-world data analysis aimed to investigate, based on the primary exposure variable (atrial fibrillation burden), primary outcome variables (ischemic stroke, systemic embolism, etc.), and secondary outcome variables (transient ischemic attack, hospitalization for heart failure, major bleeding events, all-cause mortality, etc.), whether there is a risk inflection point between atrial fibrillation burden and stroke, whether there is a reasonable threshold for the benefit of anticoagulation therapy, and whether there is a time-dependent risk of atrial fibrillation burden prior to stroke/thromboembolic events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This was a prospective, multicenter, observational cohort study of adult patients with a confirmed diagnosis of atrial fibrillation. Patients meeting the inclusion and exclusion criteria were planned to be consecutively recruited through the Cardiovascular Research Platform, with an expected total sample size of 10,000 patients and an estimated screening pool of approximately 670,000 patients. The patients were enrolled from 55 research centers across the country, covering multiple geographic regions. All enrolled patients will undergo a 24-month follow-up period, with follow-up visits scheduled at 3, 6, 12, and 24 months after enrollment. No additional interventions were applied in this study; patient management was based on local clinical practice. The primary exposure variable was the five-dimensional atrial fibrillation burden indicator, and the primary outcome was the first occurrence of ischemic stroke or systemic embolism within 12 months.
Key inclusion criteria (1 listed)
- (1) age ≥ 18 years; (2) confirmed diagnosis of atrial fibrillation (paroxysmal, persistent, or permanent); (3) ownership of a smartphone and a smartwatch, with the ability to perform basic operations; (4) provision of electronic informed consent.
Key exclusion criteria (1 listed)
- (1) presence of clear indications for anticoagulation therapy (e.g., mechanical heart valve, recent venous thromboembolism); (2) life expectancy < 1 year; (3) severe cognitive impairment or psychiatric disorder; (4) known allergy to materials used in wearable devices; (5) concurrent participation in another clinical trial that may interfere with the outcomes of this study; (6) presence of an implanted pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device; (7) pregnancy, lactation, or planned pregnancy during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to the first occurrence of the composite endpoint of clinical embolic events at 12 months of follow-up. The endpoint comprised any of the following events: ischemic stroke or systemic embolism.
Time frame: 12 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 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation Burden, run by Navy General Hospital, Beijing.
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 1 inclusion and 1 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the first occurrence of the composite endpoint of clinical embolic events at 12 months of follow-up. The endpoint comprised any of the following events: ischemic stroke or systemic embolism. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.