Atrial Fibrillation (AF)SubclincalAFNCT07447297
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
A study testing cardioversion, catheter ablation in people with Atrial Fibrillation (AF) and Diseases of the Circulatory System, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices. Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Diseases of the Circulatory System, Atrial Flutter
- What is being tested?
- cardioversion, catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2024to 31 Dec 2029
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Among patients with Cardiac implantable electronic device (CIED), subjects with atrial high rate episodes found Cardiac implantable electronic devices: implantable loop recorder, pacemaker, implantable cardioverter defibrillator(ICD), cardiac resynchronized therapy(CRT)
- Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together)
- If the accumulated period of the atrial high rate episode during the three-month observation period is more than 21 hours
- Patients whose atrial fibrillation has not been confirmed by electrocardiogram or holter monitoring within the past year from the time atrial high rate episode was detected
- However, enrollment is possible even if it includes one of the following two cases ⓐ Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring
- ⓑ If there is a record of atrial fibrillation, but Paroxysmal AF less than 30 seconds
Who cannot join
- Patients deemed inappropriate to participate in the study by the investigator
- Patients diagnosed with atrial fibrillation with 12-lead electrocardiogram or holter within the past year prior to participation in the study
- Patients taking Class Ic, III of antiarrhythmic drugs prior to study participation
- Patients who have had rhythm control treatments such as Radiofequency catheter ablation (RFCA), Total thoracoscopic ablation (TTA), Maze procedure (MAZEop), and antiarrhythmic treatment due to atrial fibrillation (except for CTI ablation with AFL)
- Patients whose life expectancy is less than one year (e.g., patients who can't even have a heart transplant, patients who receive DNR, Patients in hospice wards who refuse life-sustaining treatment, terminal cancer patients who cannot receive radiation or chemotherapy, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Kim Ju Youn, Clinical assistant professor, Ph.D, 82+ 2-3410-3419, kzzoo921@gmail.com
About this study
The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment.
Read more
Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation.
Participants will:
- Randomly allocated to two groups at a 1:1 ratio.
- Receive the treatment according to their assigned group.
- Visit the clinic once every three months for checkups and tests.
Read the detailed description
There have been reports that early rhythm control therapy reduces various heart events in patients with atrial fibrillation. The definition of "early" atrial fibrillation defined in this study was defined as a patient within one year of diagnosis. This means clinical atrial fibrillation diagnosed by 12-lead electrocardiogram.
Atrial high rate episode (AHRE) may be found through various Cardiac Electronic Implantable Devices (CIED), which is defined as subclinical atrial fibrillation. There have been many studies on the risk of such subclinical atrial fibrillation causing cerebral infarction, and meta-analysis results show that there is a high risk of thromboembolism if there is an episode of 30 seconds or the sum of duration is more than 24 hours. However, there is no research on the rhythm control therapy for patients with subclinical atrial fibrillation, and this study might be considered as an important factor in determining the truly early atrial fibrillation treatment guideline. Therefore, this study aims to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
This study is a randomized, multicenter, prospective, interventional study to observe the efficacy of early rhythm control treatment compared to general control treatment in patients with subclinical atrial fibrillation. According to the electronic random assignment program, it is divided into two groups (early rhythm control group, general control group) and allocated at a 1:1 ratio. This study is open-label study. Early rhythm control groups get rhythm control treatment for atrial fibrillation based on guidelines. This includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management (observation, heart rate control treatment if necessary) without the above atrial fibrillation rhythm control treatment. In both groups, appropriate anticoagulant treatment is given if there is an indication of cerebral infarction prevention associated with atrial fibrillation.
- Being tested
- early rhythm control group, cardioversion, catheter ablation, general control
- Keywords
- earl rhythm control, subclinical atrial fibrillation, antiarrhythmic drugs
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early rhythm control groupDrug
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on
cardioversion, catheter ablationProcedure or surgery
only when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed
general controlOther
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription.
| Study group | Role | What they receive |
|---|---|---|
| early rhythm control group | Experimental | Early rhythm control group receives atrial fibrillation rhythm control treatment based on guidelines. This includes antiarrhythmic treatment, cardioversion, and catheter ablation.
Antiarrhythmic drugs include flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on, and the doctor chooses the drug in consideration of structural heart disease, coronary artery disease, abnormal left ventricular hypertrophy, and heart failure.(Refer to the Korean Heart rhythm Society atrial Fibrillation Treatment Guidelines) Catheter ablation is a procedure that uses high-frequency energy to block the site of tachycardia in the heart. Cardioversion is a procedure that converts the electrical activity of the heart to sinus rhythm by directly giving electric shock on the surface of the heart. Catheter ablation or cardioversion is a treatment method performed only when clinical atrial fibrillation is confirmed. Receives: Drug: early rhythm control group; Procedure: cardioversion, catheter ablation |
| general control group | Active comparator | The general control group receives general management without the above atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription. Receives: Other: general control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate)
Recurrence is defined as
- either a less than 50% reduction in AF burden or the detection/occurrence of clinical AF AF control (efficacy) is defined as
- reduction in AF burden of 50% or more 10% difference in the recurrence rate between the two groups using a comparison of proportions.
Kaplan-Meier survival analysis will be performed, and the Log-rank test will be used to compare the groups.
A Cox proportional-hazards model will be performed, including the experimental group and the randomization stratification factor. The hazard ratio and its 95% confidence interval between the two groups will be presented.
Statistical significance will be determined by a P-value of < 0.05.
Measured: From enrollment to 1 year
side effects related to medication or other treatments
Measured: From enrollment to 1 year
Secondary outcomes (6)
Atrial fibrillation effect on quality-of-life questionnaire score
Atrial fibrillation effect on quality-of-life questionnaire scale 0 to 100 Score ranges from a minimum of 0 to a maximum of 100. A higher score indicates a worse outcome.
Measured: From enrollment to 1 year
cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation
Individual events and composite events will be presented using frequencies and percentages.
Cox proportional-hazards model will be performed, including the treatment group and the randomization stratification factor. The Log-rank test will be used to compare the incidence rates and hazard ratios between the experimental and active comparator groups.
Measured: From enrollment to 1 year
NTproBNP(pg/ml)
Measured in pg/mL
Measured: From enrollment to 1year
Korean Montreal Cognitive Assessment (K-MoCA)
Korean Montreal Cognitive Assessment (K-MoCA) score 0 to 30. Score ranges from a minimum of 0 to a maximum of 30, where higher scores indicate better cognitive performance.
Measured: From enrollment to 1 year
Left ventricular ejection fraction(LVEF)
LVEF in percentage as measured by echocardiography
Measured: From enrollment to 1 year
Diastolic function assessment
Calculate the E/e' ratio using the early diastolic filling velocity (E) and the early diastolic mitral annular velocity (e'), both measured in m/s.
Measured: From enrollment to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start2 Jan 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital, Korea University Anam Hospital, Keimyung University Dongsan Medical Center, Severance Hospital, Wonju Severance Christian Hospital, Asan Medical Center, Inje University Ilsan Paik Hospital, The Catholic University of Korea
- Responsible party
- Principal investigator, Ju Youn Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447297
- Sponsor's protocol ID
- SMC2023-07-195
- Other IDs
- KCT0009027
- Acronym
- SubclincalAF
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sagris D, Georgiopoulos G, Pateras K, Perlepe K, Korompoki E, Milionis H, Tsiachris D, Chan C, Lip GYH, Ntaios G. Atrial High-Rate Episode Duration Thresholds and Thromboembolic Risk: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2021 Nov 16;10(22):e022487. doi: 10.1161/JAHA.121.022487. Epub 2021 Nov 10.
PubMed 34755543Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PubMed 32860505Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
PubMed 32865375
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07447297
- Acronym / sponsor ID
- SubclincalAF / SMC2023-07-195
- Keywords
- earl rhythm control, subclinical atrial fibrillation, antiarrhythmic drugs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital, Korea University Anam Hospital, Keimyung University Dongsan Medical Center, Severance Hospital, Wonju Severance Christian Hospital, Asan Medical Center, Inje University Ilsan Paik Hospital, The Catholic University of Korea
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (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.
The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment.
Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation.
Participants will:
- Randomly allocated to two groups at a 1:1 ratio.
- Receive the treatment according to their assigned group.
- Visit the clinic once every three months for checkups and tests.
Detailed description
There have been reports that early rhythm control therapy reduces various heart events in patients with atrial fibrillation. The definition of "early" atrial fibrillation defined in this study was defined as a patient within one year of diagnosis. This means clinical atrial fibrillation diagnosed by 12-lead electrocardiogram.
Atrial high rate episode (AHRE) may be found through various Cardiac Electronic Implantable Devices (CIED), which is defined as subclinical atrial fibrillation. There have been many studies on the risk of such subclinical atrial fibrillation causing cerebral infarction, and meta-analysis results show that there is a high risk of thromboembolism if there is an episode of 30 seconds or the sum of duration is more than 24 hours. However, there is no research on the rhythm control therapy for patients with subclinical atrial fibrillation, and this study might be considered as an important factor in determining the truly early atrial fibrillation treatment guideline. Therefore, this study aims to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
This study is a randomized, multicenter, prospective, interventional study to observe the efficacy of early rhythm control treatment compared to general control treatment in patients with subclinical atrial fibrillation. According to the electronic random assignment program, it is divided into two groups (early rhythm control group, general control group) and allocated at a 1:1 ratio. This study is open-label study. Early rhythm control groups get rhythm control treatment for atrial fibrillation based on guidelines. This includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management (observation, heart rate control treatment if necessary) without the above atrial fibrillation rhythm control treatment. In both groups, appropriate anticoagulant treatment is given if there is an indication of cerebral infarction prevention associated with atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early rhythm control group | Experimental | Drug: early rhythm control group, Procedure: cardioversion, catheter ablationEarly rhythm control group receives atrial fibrillation rhythm control treatment based on guidelines. This includes antiarrhythmic treatment, cardioversion, and catheter ablation. Antiarrhythmic drugs include flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on, and the doctor chooses the drug in consideration of structural heart disease, coronary artery disease, abnormal left ventricular hypertrophy, and heart failure.(Refer to the Korean Heart rhythm Society atrial Fibrillation Treatment Guidelines) Catheter ablation is a procedure that uses high-frequency energy to block the site of tachycardia in the heart. Cardioversion is a procedure that converts the electrical activity of the heart to sinus rhythm by directly giving electric shock on the surface of the heart. Catheter ablation or cardioversion is a treatment method performed only when clinical atrial fibrillation is confirmed. |
| general control group | Active comparator | Other: general controlThe general control group receives general management without the above atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Among patients with Cardiac implantable electronic device (CIED), subjects with atrial high rate episodes found Cardiac implantable electronic devices: implantable loop recorder, pacemaker, implantable cardioverter defibrillator(ICD), cardiac resynchronized therapy(CRT)
- Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together)
- If the accumulated period of the atrial high rate episode during the three-month observation period is more than 21 hours
- Patients whose atrial fibrillation has not been confirmed by electrocardiogram or holter monitoring within the past year from the time atrial high rate episode was detected
- However, enrollment is possible even if it includes one of the following two cases ⓐ Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring
Key exclusion criteria (5 listed)
- Patients deemed inappropriate to participate in the study by the investigator
- Patients diagnosed with atrial fibrillation with 12-lead electrocardiogram or holter within the past year prior to participation in the study
- Patients taking Class Ic, III of antiarrhythmic drugs prior to study participation
- Patients who have had rhythm control treatments such as Radiofequency catheter ablation (RFCA), Total thoracoscopic ablation (TTA), Maze procedure (MAZEop), and antiarrhythmic treatment due to atrial fibrillation (except for CTI ablation with AFL)
- Patients whose life expectancy is less than one year (e.g., patients who can't even have a heart transplant, patients who receive DNR, Patients in hospice wards who refuse life-sustaining treatment, terminal cancer patients who cannot receive radiation or chemotherapy, etc.)
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 |
|---|---|---|
| early rhythm control groupflecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on | Drug | early rhythm control group |
| cardioversion, catheter ablationonly when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed | Procedure or surgery | early rhythm control group |
| general controlGeneral management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription. | Other | general control group |
Primary outcome
Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate)
Time frame: From enrollment to 1 year
Recurrence is defined as * either a less than 50% reduction in AF burden or the detection/occurrence of clinical AF AF control (efficacy) is defined as * reduction in AF burden of 50% or more 10% difference in the recurrence rate between the two groups using a comparison of proportions. Kaplan-Meier survival analysis will be performed, and the Log-rank test will be used to compare the groups. A Cox proportional-hazards model will be performed, including the experimental group and the randomization stratification factor. The hazard ratio and its 95% confidence interval between the two groups will be presented. Statistical significance will be determined by a P-value of < 0.05.
side effects related to medication or other treatments
Time frame: From enrollment to 1 year
6 secondary outcomes
Atrial fibrillation effect on quality-of-life questionnaire score
Time frame: From enrollment to 1 year
cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation
Time frame: From enrollment to 1 year
NTproBNP(pg/ml)
Time frame: From enrollment to 1year
Korean Montreal Cognitive Assessment (K-MoCA)
Time frame: From enrollment to 1 year
Left ventricular ejection fraction(LVEF)
Time frame: From enrollment to 1 year
Diastolic function assessment
Time frame: From enrollment to 1year
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 3 Mar 2026.
- Results publication: PubMed 34755543Sagris D, Georgiopoulos G, Pateras K, Perlepe K, Korompoki E, Milionis H, Tsiachris D, Chan C, Lip GYH, Ntaios G. Atrial High-Rate Episode Duration Thresholds and Thromboembolic Risk: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2021 Nov 16;10(22):e022487. doi: 10.1161/JAHA.121.022487. Epub 2021 Nov 10.
- Results publication: PubMed 32860505Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
- Results publication: PubMed 32865375Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
- 2021 KHRS Guideline of Atrial Fibrillation ManagementLink provided by the sponsor.
- 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 cardioversion, catheter ablation in people with Atrial Fibrillation (AF) and Diseases of the Circulatory System, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 5 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 3 Mar 2026. 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 South Korea. 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 Ju Youn Kim, Clinical assistant professor, MD, Ph.D (82-2-3410-3419, kzzoo921@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate) (time frame: From enrollment to 1 year). The study lists 2 primary outcomes in all. 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 NCT07447297, which also lists 3 linked publications.
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 3 Mar 2026.