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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Diagnostic test: study arm

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tze-Fan Chao, PhD; Phone Number: 886-2-28727794; Email: eyckeyck@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Taipei Veterans General Hospital; Phone Number: 886-2-28712121; Email: cv@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control arm
Active Comparator: study arm	Diagnostic test: study arm; Scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Tze-Fan Chao

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: November 29, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 2024-01-001BC; NSTC 113-2628-B-075 -002 -MY3 (Other Identifier: Ministry of Science and Technology, Taiwan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No