Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal ECHOcardiographic Parameters: The...

Atrial fibrillation (AF) screening is important because AF can be paroxysmal and asymptomatic. Although AF is closely linked to certain abnormal echocardiographic parameters, these parameters have never been incorporated as criteria for AF screening. The SAFE-ECHO study is a prospective, randomized, open-label, multicenter trial to evaluate AF detection using extended electrocardiogram (ECG) monitoring in patients without AF who meet echocardiographic criteria, including left atrial enlargement (LAE), left ventricular hypertrophy (LVH), E/e' > 14, grade II/III diastolic dysfunction, valvular heart disease (VHD), or heart failure (HF). Patients will be randomized in a 1:1 ratio to contemporary care (control arm) versus proactive staged screening (study arm). In the study arm, patients will undergo a 30-second single strip ECG and 7-day continuous ECG monitoring at enrollment and every 3 months for 1 year. The total study duration is 2 years, comprising a 1-year screening period and an additional year of follow-up. The primary endpoint is detection of new-onset AF within the 12-month screening period. The secondary endpoint is any arrhythmia of clinical significance or those requiring clinical interventions or a change of treatments. The tertiary endpoint is a composite of ischemic stroke, systemic thromboembolism, myocardial infarction, HF hospitalization, or emergent visit or mortality after the screening period, which will be evaluated for exploratory purposes only. In conclusion, the SAFE-ECHO study aims to evaluate the feasibility of specific echocardiographic parameters as criteria for AF screening and to determine the AF detection yield of scheduled extended ECG monitoring, which may help inform future AF screening strategies. Trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT07278089.