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

Navy General Hospital, Beijing

Status: Not yet enrolling

Conditions: Atrial Fibrillation Burden; Atrial Fibrillation (AF)

Study type: Observational

Funder types: Other

Identifiers

NCT07497906

S2026-022-01

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.