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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07278089
Acronym
SAFE-ECHO
Enrollment
3000
Registered
2025-12-11
Start date
2025-03-17
Completion date
2032-12-31
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

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.

Interventions

DIAGNOSTIC_TESTstudy arm

Scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring

Sponsors

Tze-Fan Chao
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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.2 years

Countries

Taiwan

Contacts

Primary ContactTze-Fan Chao, PhD
eyckeyck@gmail.com886-2-28727794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026