Atrial Fibrillation (AF)SAFE-ECHONCT07278089
AF Screening in Patients With Abnormal Echocardiographic Parameters
A study testing study arm in people with Atrial Fibrillation (AF), run by Tze-Fan Chao at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- study arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Mar 2025to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Taipei Veterans General Hospital, 886-2-28712121, cv@vghtpe.gov.tw
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- study arm
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study armDiagnostic test
Scheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring
| Study group | Role | What they receive |
|---|---|---|
| study arm | Active comparator | Not described Receives: Diagnostic Test: study arm |
| control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start17 Mar 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tze-Fan Chao
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tze-Fan Chao, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278089
- Sponsor's protocol ID
- 2024-01-001BC
- Other IDs
- NSTC 113-2628-B-075 -002 -MY3
- Acronym
- SAFE-ECHO
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 41999845
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Atrial Fibrillation/Arrhythmia Events in Patients With Abnormal Echocardiographic Parameters: The Randomized, Prospective SAFE-ECHO Study Design and Rationale
- ClinicalTrials.gov ID
- NCT07278089
- Acronym / sponsor ID
- SAFE-ECHO / 2024-01-001BC
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Tze-Fan ChaoOther government
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Active comparator | Diagnostic Test: study arm |
| control arm | No intervention | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study armScheduled cardiac rhythm monitoring every 3 months using extended continuous ECG monitoring | Diagnostic test | study arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 41999845Liao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study arm in people with Atrial Fibrillation (AF), run by Tze-Fan Chao at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tze-Fan Chao, PhD (886-2-28727794, eyckeyck@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07278089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.