RecruitingNot ApplicableNCT07278089
AF Screening in Patients With Abnormal Echocardiographic Parameters
Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal Echocardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale
Sponsor
Tze-Fan Chao
Enrollment
3,000 participants
Start Date
Mar 17, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 20 Years
Inclusion Criteria6
- 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;
- VHD;
- 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 Criteria1
- 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.
Interventions
DIAGNOSTIC_TESTstudy arm
Scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07278089
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