AF Screening in Patients With Abnormal Echocardiographic Parameters (SAFE-ECHO)

Tze-Fan Chao

Status: Enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Diagnostic Test: study arm

Study type: Interventional

Funder types: Other

Identifiers

NCT07278089

2024-01-001BC

NSTC 113-2628-B-075 -002 -MY3 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,000 participants in 2 patient groups

study arm

Active Comparator group

Treatment:

Diagnostic Test: study arm

control arm

No Intervention group