NCT07278089RecruitingNot Applicable
Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal Echocardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale
Tze-Fan Chao1 site in 1 country3,000 target enrollmentStarted: March 17, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- the detection of AF either by 12-lead ECG or any episodes of AF lasting ≥ 30 seconds by the single-lead ECG or 7-day continuous recording.
Study Overview
Brief Summary
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 compared to contemporary care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who met any of the following criteria
- •LAE: defined as LAD ≥ 45 mm or LAVI > 34 ml/m2;
- •LVH: defined as LV septal or posterior wall thickness ≥ 15 mm;
- •E/e' > 14;
- •grade II or III diastolic dysfunction;
- •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.
Outcomes
Primary Outcomes
the detection of AF either by 12-lead ECG or any episodes of AF lasting ≥ 30 seconds by the single-lead ECG or 7-day continuous recording.
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Tze-Fan Chao
Doctor
Taipei Veterans General Hospital, Taiwan
Study Sites (1)
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