Atrial Fibrillation (AF), Atrial Fibrillation Burden
Conditions
Brief 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 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.
Interventions
None listed
Sponsors
Navy General Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| 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. | 12 months |
Outcome results
None listed