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Recruiting NCT07278089

AF Screening in Patients With Abnormal Echocardiographic Parameters

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: study arm.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test study arm
    Scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring

Primary outcome measures

  • 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]

Eligibility criteria

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;
  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Taiwan · 1 center
  • Taipei Veterans General Hospital — Taipei

Publications

  • Liao JN, Kuo L, Liu CM, Tsai CT, Chang HC, Hung CL, Chao TF, Yu WC. Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal ECHOcardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale. Am J Cardiol. 2026 Jul 1;270:97-104. doi: 10.1016/j.amjcard.2026.03.074. Epub 2026 Apr 16. PMID 41999845

Identifiers

NCT: NCT07278089 · 2024-01-001BC · NSTC 113-2628-B-075 -002 -MY3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗