Screening for Atrial Fibrillation in Adults With Abnormal Echocardiogram Results Using Scheduled ECG Monitoring
Led by Tze-Fan Chao · Updated on 2025-12-11
3000
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of specific echocardiographic measurements to identify patients at risk for atrial fibrillation AF and to compare the detection rates of scheduled extended ECG monitoring against standard care. The study aims to determine how well these heart ultrasound parameters can guide AF screening and improve early diagnosis.
Participants are randomly assigned to either a study group receiving scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG devices or a control group receiving no intervention. The ECG monitoring includes single-lead and 7-day continuous recordings to detect episodes of AF lasting 30 seconds or longer.
During the two-year study, participants will undergo regular ECG assessments to detect AF events. Researchers will measure the occurrence of AF through 12-lead ECG or prolonged ECG recordings. Safety and health status will be monitored throughout the trial, with no masking or blinding involved.
CONDITIONS
Brief Title
AF Screening in Patients With Abnormal Echocardiographic Parameters
Research Team
T
Tze-Fan Chao, PhD
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Left atrial enlargement defined as left atrial diameter 245 mm or left atrial volume index > 34 ml/m2
Left ventricular hypertrophy with septal or posterior wall thickness 215 mm
E/e' ratio greater than 14
Grade II or III diastolic dysfunction
Presence of valvular heart disease
Heart failure with left ventricular ejection fraction < 40% or 240% with clinical signs per Framingham criteria, NYHA class II-IV, and NT-proBNP > 125 pg/ml
You will not qualify if you...
History of atrial fibrillation or atrial flutter
Congenital heart disease
Acute coronary syndrome treated with urgent PCI within past 3 months
Uncontrolled hyperthyroidism
End-stage renal disease
Unstable hemodynamic status
Any major comorbidities or medical conditions with expected life expectancy less than 1 year
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 2 years
Participants undergo scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring to detect atrial fibrillation or arrhythmia events.
Quarterly visits every 3 months for up to 2 years
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal ECHOcardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale.