Burden-Evaluated Atrial Fibrillation Progession and ThromboEmbolim Study BEAT-AF TE Study

March 23, 2026 updated by: Navy General Hospital, Beijing
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Navy General Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2026-022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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