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)

Taipei Veterans General Hospital

Taipei, Taiwan

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NCT07278089


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