Atrial FibrillationNCT07197931
EXPORT Randomized Trial
A study testing Additional extra-pulmonary vein trigger ablation group and Empirical pulmonary vein isolation group in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Pulmonary Vein Isolation (PVI)-Only Group 1. Pulmonary vein isolation (PVI) will be performed, and the procedure will be terminated without the administration of isoproterenol following the standard waiting period. 2. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Additional extra-pulmonary vein trigger ablation group and Empirical pulmonary vein isolation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2025to 31 Aug 2030
- 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
- Patients aged ≥19 years with persistent atrial fibrillation scheduled for catheter ablation.
- Refractory to or intolerant of at least one Class I or III antiarrhythmic drug.
- Undergoing first-time catheter ablation for atrial fibrillation.
Who cannot join
- Acute coronary syndrome within the past 3 months.
- Severe unrevascularized coronary artery disease: ≥70% stenosis in at least one major epicardial vessel with a diameter ≥2 mm.
- History of stroke or transient ischemic attack (TIA) within the past 3 months.
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg).
- Severe untreated aortic valve stenosis.
- Symptomatic moderate-to-severe valvular heart disease.
Show all 19Show fewer
- Aortic dissection.
- Heart failure with reduced ejection fraction (LVEF <40%).
- Severe pulmonary hypertension (resting RVSP >60 mmHg).
- Left atrial anteroposterior diameter >60 mm.
- Presence of cyanotic congenital heart disease.
- Obstructive hypertrophic cardiomyopathy (resting or provoked LVOT pressure gradient ≥30 mmHg).
- History of prior maze surgery or catheter ablation for atrial fibrillation.
- Active internal bleeding.
- Contraindications to anticoagulation therapy or rhythm control treatment.
- Presence of severe comorbid conditions or life expectancy <1 year.
- Drug or alcohol abuse.
- Pregnancy.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
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
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
About this study
Official title: Comparison of Circumferential Pulmonary Vein (PV) Isolation Alone Versus Additional EXtra-PulmOnaRy Vein Trigger Ablation in Persistent Atrial Fibrillation
Pulmonary Vein Isolation (PVI)-Only Group
- Pulmonary vein isolation (PVI) will be performed, and the procedure will be terminated without the administration of isoproterenol following the standard waiting period.
- In cases where spontaneous triggers are observed following PVI, mapping and ablation of the identified triggers are permitted.
- Post-procedural rhythm monitoring and follow-up will be conducted in accordance with the predefined study protocol.
Read more
Additional Non-Pulmonary Vein (Non-PV) Trigger Ablation Group
Isoproterenol will be administered starting at 5 μg/min, with stepwise increases to 10 μg/min and 20 μg/min at 3-5 minute intervals, as tolerated, aiming to achieve 85% of the maximum predicted heart rate, with a maximum dose of 30 μg/min.The total infusion duration will be at least 10 minutes.
- If systolic blood pressure (SBP) decreases by ≥20 mmHg from the baseline (prior to infusion), the isoproterenol infusion will be discontinued.
- If hypotension is anticipated or occurs during isoproterenol infusion, phenylephrine infusion may be administered to maintain SBP between 120-140 mmHg.
- For patients with a history of coronary artery disease, heart failure, or valvular heart disease, the maximum isoproterenol infusion rate may be limited to ≤10 μg/min at the discretion of the operator.
Read the detailed description
"A. Essential Standard Pre-Procedural Examinations for Catheter Ablation
- Transthoracic Echocardiography (TTE): Performed in all patients to evaluate the presence of structural heart disease, left atrial size, and left ventricular function. Findings guide the selection of antiarrhythmic medications and assist in determining procedural indications.
- Transesophageal or Intracardiac Echocardiography: Conducted in all patients prior to the procedure to detect thrombi within the left atrial appendage, thereby minimizing the risk of post-procedural cerebrovascular events.
- Three-Dimensional Cardiac CT Imaging (substitutable with Cardiac Magnetic Resonance Imaging if clinically indicated): Performed in all patients before the procedure to generate a three-dimensional anatomical model of the left atrium by integrating voltage mapping and contour data from CT images. This approach enhances procedural accuracy and reduces the incidence of procedure-related complications.
- The most recent test results prior to the procedure should be utilized preferentially; in the absence of recent data, prior examination results may be used as substitutes.
- Administration of Medications Before and After Catheter Ablation
- Anticoagulant therapy will be administered for a period of one month prior to and for a minimum of two months following the catheter ablation procedure, in order to reduce the risk of thromboembolic events, including stroke. Should the risk of stroke remain elevated due to atrial fibrillation recurrence or other clinical considerations, continuation of anticoagulation therapy may be determined at the discretion of the treating physician.
- In cases where recurrence of atrial fibrillation is suspected, or if there is a clinically assessed high likelihood of recurrence, antiarrhythmic medications may be prescribed based on the clinical judgment of the physician.
- Conditions
- Atrial Fibrillation
- Being tested
- Additional extra-pulmonary vein trigger ablation group, Empirical pulmonary vein isolation group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional extra-pulmonary vein trigger ablation groupProcedure or surgery
- Circumferential PVI is performed in all patients.
- After PVI, isoproterenol is infused starting at 5 μg/min, increased every 3-5 min to 10 and 20 μg/min (max 30 μg/min) to reach 85% of predicted heart rate for ≥10 min. 2-1) If AF persists, internal cardioversion (5-30 J) is performed using catheters in the right atrium and coronary sinus. 2-2) If sinus rhythm is present, a 15-beat drive train (10 mA, 2 ms) is delivered at 250 ms, shortened by 10 ms to 180 ms or until capture fails, up to three times, to induce AF or AT. Isoproterenol continues for 2 min. If arrhythmia occurs, cardioversion is repeated.
- After cardioversion, isoproterenol is stopped and the patient is observed for 10 min.
- Sustained or reproducible arrhythmias are defined as non-PV triggers.
- These are localized with activation mapping, P-wave analysis, and high-density mapping.
- Ablation is performed with the same catheter.
- Reassessment is done with the same protocol.
Empirical pulmonary vein isolation groupProcedure or surgery
- Circumferential pulmonary vein isolation (PVI) is performed in all patients.
- After PVI, a waiting period of at least 20 minutes is observed, followed by reassessment of pulmonary vein isolation before concluding the procedure.
- Additional linear ablation or CFAE ablation not specified in the study protocol should be avoided whenever possible.
- In cases where typical atrial flutter has been documented prior to the procedure or is induced during the procedure, cavo-tricuspid isthmus (CTI) ablation is performed. At the operator's discretion, CTI ablation may also be permitted even in patients without a prior history or inducibility.
- If atypical atrial flutter involving these pathways is induced during the procedure, additional linear ablation (e.g., roof line, posterior-inferior line, left lateral isthmus, or anterior line) may be performed.
| Study group | Role | What they receive |
|---|---|---|
| Additional extra-pulmonary vein trigger ablation group | Experimental | circumferential pulmonary vein isolation with additive induction, mapping, and ablation of non-pulmonary vein trigger Receives: Procedure: Additional extra-pulmonary vein trigger ablation group |
| Empirical pulmonary vein isolation group | Active comparator | circumferential pulmonary vein isolation only Receives: Procedure: Empirical pulmonary vein isolation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial arrhythmia
any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
Measured: within 24 months after enrollement
Secondary outcomes (5)
Recurrence of atrial arrhythmia or use of antiarrhythmic drug
any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period following ablation or the use of antiarrhythmic drug use
Measured: within 24 months after enrollement
Recurrence of atrial fibrillation
any documented atrial fibrillation lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
Measured: within 24 months after enrollement
Recurrence of atrial tachycardia/flutter
any documented atrial tachycardia/flutter lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
Measured: within 24 months after enrollement
Cardioversion rate
any cardioversion performed following ablation
Measured: within 24 months after enrollement
Complication rate
any complication related to ablation
Measured: within 24 months after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study startOct 2025 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (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 FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197931
- Sponsor's protocol ID
- 2025-1476-001
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim D, Lee KY, Park H, Yu HT, Kim TH, Roh SY, Uhm JS, Joung B, Lee DI, Kim YH, Pak HN. Rationale and design of a multicenter randomized trial of adjunctive non-pulmonary vein trigger ablation in persistent atrial fibrillation: The EXPORT trial. Am Heart J. 2026 Oct 1:107624. doi: 10.1016/j.ahj.2026.107624. Online ahead of print.
PubMed 42822815
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Circumferential Pulmonary Vein (PV) Isolation Alone Versus Additional EXtra-PulmOnaRy Vein Trigger Ablation in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07197931
- Acronym / sponsor ID
- 2025-1476-001
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 30 Sep 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.
Pulmonary Vein Isolation (PVI)-Only Group
- Pulmonary vein isolation (PVI) will be performed, and the procedure will be terminated without the administration of isoproterenol following the standard waiting period.
- In cases where spontaneous triggers are observed following PVI, mapping and ablation of the identified triggers are permitted.
- Post-procedural rhythm monitoring and follow-up will be conducted in accordance with the predefined study protocol.
Additional Non-Pulmonary Vein (Non-PV) Trigger Ablation Group
Isoproterenol will be administered starting at 5 μg/min, with stepwise increases to 10 μg/min and 20 μg/min at 3-5 minute intervals, as tolerated, aiming to achieve 85% of the maximum predicted heart rate, with a maximum dose of 30 μg/min.The total infusion duration will be at least 10 minutes.
- If systolic blood pressure (SBP) decreases by ≥20 mmHg from the baseline (prior to infusion), the isoproterenol infusion will be discontinued.
- If hypotension is anticipated or occurs during isoproterenol infusion, phenylephrine infusion may be administered to maintain SBP between 120-140 mmHg.
- For patients with a history of coronary artery disease, heart failure, or valvular heart disease, the maximum isoproterenol infusion rate may be limited to ≤10 μg/min at the discretion of the operator.
Detailed description
"A. Essential Standard Pre-Procedural Examinations for Catheter Ablation
- Transthoracic Echocardiography (TTE): Performed in all patients to evaluate the presence of structural heart disease, left atrial size, and left ventricular function. Findings guide the selection of antiarrhythmic medications and assist in determining procedural indications.
- Transesophageal or Intracardiac Echocardiography: Conducted in all patients prior to the procedure to detect thrombi within the left atrial appendage, thereby minimizing the risk of post-procedural cerebrovascular events.
- Three-Dimensional Cardiac CT Imaging (substitutable with Cardiac Magnetic Resonance Imaging if clinically indicated): Performed in all patients before the procedure to generate a three-dimensional anatomical model of the left atrium by integrating voltage mapping and contour data from CT images. This approach enhances procedural accuracy and reduces the incidence of procedure-related complications.
- The most recent test results prior to the procedure should be utilized preferentially; in the absence of recent data, prior examination results may be used as substitutes.
- Administration of Medications Before and After Catheter Ablation
- Anticoagulant therapy will be administered for a period of one month prior to and for a minimum of two months following the catheter ablation procedure, in order to reduce the risk of thromboembolic events, including stroke. Should the risk of stroke remain elevated due to atrial fibrillation recurrence or other clinical considerations, continuation of anticoagulation therapy may be determined at the discretion of the treating physician.
- In cases where recurrence of atrial fibrillation is suspected, or if there is a clinically assessed high likelihood of recurrence, antiarrhythmic medications may be prescribed based on the clinical judgment of the physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional extra-pulmonary vein trigger ablation group | Experimental | Procedure: Additional extra-pulmonary vein trigger ablation groupcircumferential pulmonary vein isolation with additive induction, mapping, and ablation of non-pulmonary vein trigger |
| Empirical pulmonary vein isolation group | Active comparator | Procedure: Empirical pulmonary vein isolation groupcircumferential pulmonary vein isolation only |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥19 years with persistent atrial fibrillation scheduled for catheter ablation.
- Refractory to or intolerant of at least one Class I or III antiarrhythmic drug.
- Undergoing first-time catheter ablation for atrial fibrillation.
Key exclusion criteria (19 listed)
- Acute coronary syndrome within the past 3 months.
- Severe unrevascularized coronary artery disease: ≥70% stenosis in at least one major epicardial vessel with a diameter ≥2 mm.
- History of stroke or transient ischemic attack (TIA) within the past 3 months.
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg).
- Severe untreated aortic valve stenosis.
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 |
|---|---|---|
| Additional extra-pulmonary vein trigger ablation group1. Circumferential PVI is performed in all patients. 2. After PVI, isoproterenol is infused starting at 5 μg/min, increased every 3-5 min to 10 and 20 μg/min (max 30 μg/min) to reach 85% of predicted heart rate for ≥10 min. 2-1) If AF persists, internal cardioversion (5-30 J) is performed using catheters in the right atrium and coronary sinus. 2-2) If sinus rhythm is present, a 15-beat drive train (10 mA, 2 ms) is delivered at 250 ms, shortened by 10 ms to 180 ms or until capture fails, up to three times, to induce AF or AT. Isoproterenol continues for 2 min. If arrhythmia occurs, cardioversion is repeated. 3. After cardioversion, isoproterenol is stopped and the patient is observed for 10 min. 4. Sustained or reproducible arrhythmias are defined as non-PV triggers. 5. These are localized with activation mapping, P-wave analysis, and high-density mapping. 6. Ablation is performed with the same catheter. 7. Reassessment is done with the same protocol. | Procedure or surgery | Additional extra-pulmonary vein trigger ablation group |
| Empirical pulmonary vein isolation group1. Circumferential pulmonary vein isolation (PVI) is performed in all patients. 2. After PVI, a waiting period of at least 20 minutes is observed, followed by reassessment of pulmonary vein isolation before concluding the procedure. 3. Additional linear ablation or CFAE ablation not specified in the study protocol should be avoided whenever possible. 4. In cases where typical atrial flutter has been documented prior to the procedure or is induced during the procedure, cavo-tricuspid isthmus (CTI) ablation is performed. At the operator's discretion, CTI ablation may also be permitted even in patients without a prior history or inducibility. 5. If atypical atrial flutter involving these pathways is induced during the procedure, additional linear ablation (e.g., roof line, posterior-inferior line, left lateral isthmus, or anterior line) may be performed. | Procedure or surgery | Empirical pulmonary vein isolation group |
Primary outcome
Recurrence of atrial arrhythmia
Time frame: within 24 months after enrollement
any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period following ablation with or without the use of antiarrhythmic drug use
5 secondary outcomes
Recurrence of atrial arrhythmia or use of antiarrhythmic drug
Time frame: within 24 months after enrollement
Recurrence of atrial fibrillation
Time frame: within 24 months after enrollement
Recurrence of atrial tachycardia/flutter
Time frame: within 24 months after enrollement
Cardioversion rate
Time frame: within 24 months after enrollement
Complication rate
Time frame: within 24 months after enrollement
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 30 Sep 2025.
- Derived from this study: PubMed 42822815Kim D, Lee KY, Park H, Yu HT, Kim TH, Roh SY, Uhm JS, Joung B, Lee DI, Kim YH, Pak HN. Rationale and design of a multicenter randomized trial of adjunctive non-pulmonary vein trigger ablation in persistent atrial fibrillation: The EXPORT trial. Am Heart J. 2026 Oct 1:107624. doi: 10.1016/j.ahj.2026.107624. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional extra-pulmonary vein trigger ablation group and Empirical pulmonary vein isolation group in people with Atrial Fibrillation, run by Yonsei University 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 3 inclusion and 19 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: opening soon, as of the sponsor's last update on 30 Sep 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial arrhythmia (time frame: within 24 months after enrollement). 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 NCT07197931, 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 30 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.