Atrial FibrillationNCT07783984
Thoracoscopic Versus Catheter Ablation in Persistent Atrial Fibrillation With Enlarged Left Atrium
A study testing Thoracoscopic ablation and Percutaneous catheter ablation in people with Atrial Fibrillation and Thoracoscopic Ablation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a prospective, single-center, open-label, randomized controlled trial comparing thoracoscopic surgical ablation with percutaneous endocardial catheter ablation as the first rhythm-control procedure in patients with persistent atrial fibrillation and an enlarged left atrium (LA diameter ≥50 mm or LA volume… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation, Thoracoscopic Ablation, Endocardial Ablation
- What is being tested?
- Thoracoscopic ablation and Percutaneous catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2024to 1 May 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
- Age 19 years or older
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy, or in whom antiarrhythmic drug therapy cannot be maintained
- European Heart Rhythm Association (EHRA) symptom score ≥ 2
- Considered suitable for rhythm-control therapy by either percutaneous catheter ablation or thoracoscopic ablation, at the investigator's medical discretion
- Enlarged left atrium, defined as left atrial diameter ≥ 50 mm or left atrial volume index ≥ 45 mL/m²
Who cannot join
- Previous percutaneous catheter ablation or thoracoscopic ablation for atrial fibrillation
- Previous thoracic or cardiac surgery
- Absolute contraindication to anticoagulation therapy
- Life expectancy less than 1 year due to non-cardiac disease, or anticipated poor adherence to treatment, at the investigator's medical discretion
- Refusal to participate in the study
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
Young Keun On, MD, PhD, +82-2-3410-2578, yk.on@samsung.com
abcd186a@naver.com
About this study
Official title: Endocardial Catheter Ablation Versus Thoracoscopic Ablation in De Novo Persistent Atrial Fibrillation Patients With Enlarged Left Atrium: A Randomized Controlled Trial
This is a prospective, single-center, open-label, randomized controlled trial comparing thoracoscopic surgical ablation with percutaneous endocardial catheter ablation as the first rhythm-control procedure in patients with persistent atrial fibrillation and an enlarged left atrium (LA diameter ≥50 mm or LA volume index ≥45 mL/m²).
A total of 194 patients who have never undergone an ablation procedure for atrial fibrillation will be randomly assigned 1:1 to thoracoscopic ablation or percutaneous catheter ablation, stratified by duration of atrial fibrillation. The primary endpoint is recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) after a 3-month blanking period. The investigators hypothesize that thoracoscopic ablation will significantly reduce recurrence compared with catheter ablation in this population.
A secondary hypothesis is that 14-day patch monitoring detects recurrent atrial tachyarrhythmia more sensitively than conventional 24-hour Holter monitoring.
Read the detailed description
Pulmonary vein isolation is an established rhythm-control therapy for symptomatic atrial fibrillation refractory to antiarrhythmic drugs. Its efficacy is lower in persistent than in paroxysmal atrial fibrillation, and additional substrate modification of the left atrium is frequently required.
Percutaneous catheter ablation (radiofrequency, cryoballoon or PFA) and thoracoscopic surgical ablation are both used in current practice. Thoracoscopic ablation additionally allows epicardial pulmonary vein isolation, ganglionated plexi ablation, dissection of the ligament of Marshall, and left atrial appendage exclusion, at the cost of a longer hospital stay and a higher incidence of post-procedural pericarditis. Recent trials have shown broadly comparable efficacy and safety between the two approaches, so both are used interchangeably in practice.
In a retrospective analysis of the institutional ablation registry at the study site, overall outcomes of the two strategies were comparable, but among patients with an enlarged left atrium thoracoscopic ablation was associated with significantly lower recurrence of atrial tachyarrhythmia. Because that finding came from a subgroup of a retrospective cohort, it could not support a firm conclusion.
This trial therefore prospectively tests, in patients with persistent atrial fibrillation and an enlarged left atrium undergoing a first rhythm-control procedure, whether thoracoscopic ablation is superior to percutaneous catheter ablation.
Post-procedural management is identical in both arms: a 3-month blanking period, discontinuation of antiarrhythmic drugs at 3 months (up to 6 months) if sinus rhythm is maintained, and anticoagulation for at least 3 months with subsequent decisions based on recurrence, prior stroke, and CHA2DS2-VASc score. Follow-up visits occur at 3, 6, and 12 months and every 6 months thereafter until 1 year after the last patient is enrolled. Rhythm monitoring uses 12-lead ECG, 24-hour Holter (3, 6, 12 months), and 14-day patch monitoring; echocardiography and NT-proBNP are obtained at baseline, 12 months, and annually thereafter.
- Being tested
- Thoracoscopic ablation, Percutaneous catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic ablationProcedure or surgery
Thoracoscopic surgical ablation is performed according to the standard technique. Pulmonary vein isolation and left atrial appendage exclusion are mandatory. Additional lesions are at the operator's discretion.
Percutaneous catheter ablationProcedure or surgery
Percutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy. Pulmonary vein isolation is mandatory. Additional lesions are at the operator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic ablation | Experimental | Thoracoscopic surgical ablation is performed according to the standard technique. Pulmonary vein isolation and left atrial appendage exclusion are mandatory. Additional lesions are at the operator's discretion. Receives: Procedure: Thoracoscopic ablation |
| Percutaneous catheter ablation | Active comparator | Percutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy. Pulmonary vein isolation is mandatory. Additional lesions are at the operator's discretion. Receives: Procedure: Percutaneous catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial tachyarrhythmia
Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, defined as an episode documented on 12-lead ECG or sustained for at least 30 seconds on continuous monitoring (14-day patch monitor or 24-hour Holter). Recurrences during the 3-month blanking period are not counted as events.
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Secondary outcomes (8)
Recurrence of atrial fibrillation
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Recurrence of atrial flutter
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Recurrence of atrial tachycardia
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
All-cause death
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Cardiac death
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Stroke
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Hospitalization for heart failure
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Procedure-related complications
Measured: From 3 months after the index procedure until 1 year after enrollment of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 May 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Keun On, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783984
- Sponsor's protocol ID
- SMC 2023-06-103
- Other IDs
- KCT0009360
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocardial Catheter Ablation Versus Thoracoscopic Ablation in De Novo Persistent Atrial Fibrillation Patients With Enlarged Left Atrium: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07783984
- Acronym / sponsor ID
- SMC 2023-06-103
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 25 Aug 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.
This is a prospective, single-center, open-label, randomized controlled trial comparing thoracoscopic surgical ablation with percutaneous endocardial catheter ablation as the first rhythm-control procedure in patients with persistent atrial fibrillation and an enlarged left atrium (LA diameter ≥50 mm or LA volume index ≥45 mL/m²).
A total of 194 patients who have never undergone an ablation procedure for atrial fibrillation will be randomly assigned 1:1 to thoracoscopic ablation or percutaneous catheter ablation, stratified by duration of atrial fibrillation. The primary endpoint is recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) after a 3-month blanking period. The investigators hypothesize that thoracoscopic ablation will significantly reduce recurrence compared with catheter ablation in this population.
A secondary hypothesis is that 14-day patch monitoring detects recurrent atrial tachyarrhythmia more sensitively than conventional 24-hour Holter monitoring.
Detailed description
Pulmonary vein isolation is an established rhythm-control therapy for symptomatic atrial fibrillation refractory to antiarrhythmic drugs. Its efficacy is lower in persistent than in paroxysmal atrial fibrillation, and additional substrate modification of the left atrium is frequently required.
Percutaneous catheter ablation (radiofrequency, cryoballoon or PFA) and thoracoscopic surgical ablation are both used in current practice. Thoracoscopic ablation additionally allows epicardial pulmonary vein isolation, ganglionated plexi ablation, dissection of the ligament of Marshall, and left atrial appendage exclusion, at the cost of a longer hospital stay and a higher incidence of post-procedural pericarditis. Recent trials have shown broadly comparable efficacy and safety between the two approaches, so both are used interchangeably in practice.
In a retrospective analysis of the institutional ablation registry at the study site, overall outcomes of the two strategies were comparable, but among patients with an enlarged left atrium thoracoscopic ablation was associated with significantly lower recurrence of atrial tachyarrhythmia. Because that finding came from a subgroup of a retrospective cohort, it could not support a firm conclusion.
This trial therefore prospectively tests, in patients with persistent atrial fibrillation and an enlarged left atrium undergoing a first rhythm-control procedure, whether thoracoscopic ablation is superior to percutaneous catheter ablation.
Post-procedural management is identical in both arms: a 3-month blanking period, discontinuation of antiarrhythmic drugs at 3 months (up to 6 months) if sinus rhythm is maintained, and anticoagulation for at least 3 months with subsequent decisions based on recurrence, prior stroke, and CHA2DS2-VASc score. Follow-up visits occur at 3, 6, and 12 months and every 6 months thereafter until 1 year after the last patient is enrolled. Rhythm monitoring uses 12-lead ECG, 24-hour Holter (3, 6, 12 months), and 14-day patch monitoring; echocardiography and NT-proBNP are obtained at baseline, 12 months, and annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic ablation | Experimental | Procedure: Thoracoscopic ablationThoracoscopic surgical ablation is performed according to the standard technique. Pulmonary vein isolation and left atrial appendage exclusion are mandatory. Additional lesions are at the operator's discretion. |
| Percutaneous catheter ablation | Active comparator | Procedure: Percutaneous catheter ablationPercutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy. Pulmonary vein isolation is mandatory. Additional lesions are at the operator's discretion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 19 years or older
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy, or in whom antiarrhythmic drug therapy cannot be maintained
- European Heart Rhythm Association (EHRA) symptom score ≥ 2
- Considered suitable for rhythm-control therapy by either percutaneous catheter ablation or thoracoscopic ablation, at the investigator's medical discretion
- Enlarged left atrium, defined as left atrial diameter ≥ 50 mm or left atrial volume index ≥ 45 mL/m²
Key exclusion criteria (5 listed)
- Previous percutaneous catheter ablation or thoracoscopic ablation for atrial fibrillation
- Previous thoracic or cardiac surgery
- Absolute contraindication to anticoagulation therapy
- Life expectancy less than 1 year due to non-cardiac disease, or anticipated poor adherence to treatment, at the investigator's medical discretion
- Refusal to participate in the study
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 |
|---|---|---|
| Thoracoscopic ablationThoracoscopic surgical ablation is performed according to the standard technique. Pulmonary vein isolation and left atrial appendage exclusion are mandatory. Additional lesions are at the operator's discretion. | Procedure or surgery | Thoracoscopic ablation |
| Percutaneous catheter ablationPercutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy. Pulmonary vein isolation is mandatory. Additional lesions are at the operator's discretion. | Procedure or surgery | Percutaneous catheter ablation |
Primary outcome
Recurrence of atrial tachyarrhythmia
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, defined as an episode documented on 12-lead ECG or sustained for at least 30 seconds on continuous monitoring (14-day patch monitor or 24-hour Holter). Recurrences during the 3-month blanking period are not counted as events.
8 secondary outcomes
Recurrence of atrial fibrillation
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Recurrence of atrial flutter
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Recurrence of atrial tachycardia
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
All-cause death
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Cardiac death
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Stroke
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Hospitalization for heart failure
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
Procedure-related complications
Time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient
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 25 Aug 2026.
- Individual participant dataSharing planned: No
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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 Thoracoscopic ablation and Percutaneous catheter ablation in people with Atrial Fibrillation and Thoracoscopic Ablation, 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 5 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 25 Aug 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 Young Keun On, MD, PhD (+82-2-3410-2578, yk.on@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial tachyarrhythmia (time frame: From 3 months after the index procedure until 1 year after enrollment of the last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.