What is this study trying to find out about atrial fibrillation?

This study is investigating whether specific echocardiographic heart measurements can help screen for atrial fibrillation and how effective scheduled extended ECG monitoring is compared to usual care. The goal is to improve early detection of AF in patients with abnormal heart ultrasound findings. The research is led by Tze-Fan Chao.

Who may be eligible for this atrial fibrillation clinical trial?

Adults aged 20 years or older with certain abnormal echocardiographic heart measurements may be eligible. Participants should not have a history of atrial fibrillation or atrial flutter and must not have major health issues that limit life expectancy. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this atrial fibrillation clinical trial?

Study-related care, including the study procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 20Years +

All Genders

ID07278089

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

Led by Tze-Fan Chao · Updated on 2025-12-11

3000

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of specific echocardiographic measurements to identify patients at risk for atrial fibrillation (AF) and to compare the detection rates of scheduled extended ECG monitoring against standard care. The study aims to determine how well these heart ultrasound parameters can guide AF screening and improve early diagnosis. Participants are randomly assigned to either a study group receiving scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG devices or a control group receiving no intervention. The ECG monitoring includes single-lead and 7-day continuous recordings to detect episodes of AF lasting 30 seconds or longer. During the two-year study, participants will undergo regular ECG assessments to detect AF events. Researchers will measure the occurrence of AF through 12-lead ECG or prolonged ECG recordings. Safety and health status will be monitored throughout the trial, with no masking or blinding involved.

CONDITIONS

Brief Title

AF Screening in Patients With Abnormal Echocardiographic Parameters

Who Can Participate

Age: 20Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 20 years or older
Left atrial enlargement defined as left atrial diameter 245 mm or left atrial volume index > 34 ml/m2
Left ventricular hypertrophy with septal or posterior wall thickness 215 mm
E/e' ratio greater than 14
Grade II or III diastolic dysfunction
Presence of valvular heart disease
Heart failure with left ventricular ejection fraction < 40% or 240% with clinical signs per Framingham criteria, NYHA class II-IV, and NT-proBNP > 125 pg/ml

You will not qualify if you...

History of atrial fibrillation or atrial flutter
Congenital heart disease
Acute coronary syndrome treated with urgent PCI within past 3 months
Uncontrolled hyperthyroidism
End-stage renal disease
Unstable hemodynamic status
Any major comorbidities or medical conditions with expected life expectancy less than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 2 years

Participants undergo scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring to detect atrial fibrillation or arrhythmia events.

Quarterly visits every 3 months for up to 2 years

Trial Site Locations

Total: 1 location

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Actively Recruiting

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Research Team

Tze-Fan Chao, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

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Frequently Asked Questions

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