Atrial fibrillation screening for people with abnormal echocardiograms

Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal Echocardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale

We will see if using certain abnormal echocardiogram measurements to select people for scheduled extended ECG monitoring finds more atrial fibrillation than usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3000 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Taipei Veterans General Hospital, Taiwan (Government)
• Locations: 1 site (Taipei)
• Trial ID: NCT07278089 on ClinicalTrials.gov

What this trial studies

This interventional study enrolls patients without prior atrial fibrillation who meet specific abnormal echocardiographic criteria (for example left atrial enlargement, left ventricular hypertrophy, elevated E/e', grade II–III diastolic dysfunction, significant valvular disease, or heart failure). Enrolled participants receive scheduled extended ECG monitoring and the AF detection yield is compared with contemporary care. The primary focus is feasibility of using predefined echo thresholds as triggers for screening and quantifying incremental AF detection. All enrollment and monitoring occur at Taipei Veterans General Hospital.

Who should consider this trial

Good fit: Ideal candidates are adults without prior AF who have abnormal echocardiogram findings such as left atrial enlargement, left ventricular hypertrophy, elevated E/e', moderate–severe diastolic dysfunction, significant valvular disease, or heart failure as defined in the criteria.

Not a fit: Patients with a history of atrial fibrillation or atrial flutter, recent urgent coronary interventions, uncontrolled hyperthyroidism, end‑stage renal disease, unstable hemodynamics, major comorbidities with life expectancy under one year, or congenital heart disease are excluded and unlikely to benefit from this screening approach.

Why it matters

Potential benefit: If successful, this approach could find atrial fibrillation earlier in high-risk patients so they can start treatment to reduce stroke and other complications.

How similar studies have performed: Extended ECG monitoring has been shown in other trials to increase AF detection, and echocardiographic markers like left atrial enlargement and elevated filling pressures are known predictors of AF, though prospectively using specific echo thresholds to guide screening is relatively novel.

Eligibility criteria

Inclusion Criteria: patients who met any of the following criteria

1. LAE: defined as LAD ≥ 45 mm or LAVI \> 34 ml/m2;
2. LVH: defined as LV septal or posterior wall thickness ≥ 15 mm;
3. E/e' \> 14;
4. grade II or III diastolic dysfunction;
5. VHD;
6. HF: defined as LVEF \< 40% or LVEF ≥40% with clinical presentation compatible with Framingham criteria, New York Heart Association functional classification II-IV, and N-terminal pro-B type natriuretic peptide (NT-proBNP) \> 125 pg/ml.

Exclusion Criteria:

* Patients with a history of AF or atrial flutter, congenital heart disease, acute coronary syndrome undergoing urgent percutaneous coronary intervention within 3 months, uncontrolled hyperthyroidism, end-stage renal disease, unstable hemodynamic status or any known major comorbidities or medical conditions with expected life expectancy less than 1 year are excluded.

Where this trial is running

Taipei

• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Tze-Fan Chao, PhD

Conditions Atrial Fibrillation