Atrial Fibrillation (AF)POBI-PFANCT06929897
PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF
A study testing Pulmonary Vein Isolation, Additional Left Atrial Posterior Wall Ablation and Non-PV trigger test in people with Atrial Fibrillation (AF), run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
To date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in several studies, and its clinical application is expanding. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulmonary Vein Isolation, Additional Left Atrial Posterior Wall Ablation and Non-PV trigger test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2026to 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80 years who are candidates for catheter ablation for persistent atrial fibrillation
- Patients eligible for catheter ablation according to existing clinical guidelines
- Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)
- Those without contraindications to anticoagulation therapy
Who cannot join
- Atrial fibrillation associated with severe congenital heart disease or structural heart disease
- Patients with contraindications to general anesthesia or sedation for the procedure
- History of prior cardiac surgery (e.g., Maze procedure, coronary artery bypass grafting)
- History of atrial fibrillation catheter ablation within the past 12 months
- Patients with severe left ventricular dysfunction (left ventricular ejection fraction <30%)
- Patients with active internal bleeding
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- Patients with contraindications to anticoagulation therapy and antiarrhythmic drugs
- Valvular atrial fibrillation (e.g., mitral stenosis > grade 2, mechanical valve, prior mitral valve repair)
- Patients with severe comorbid conditions
- Patients with an expected survival of less than one year
- Patients with drug or alcohol addiction
- Pregnant or breastfeeding women
- Any other conditions deemed by the investigator to make 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.
About this study
Official title: Comparison of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation With Posterior Wall Isolation for Pulse-Field Ablation in Persistent Atrial Fibrillation: A Prospective Randomized Controlled Trial
To date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in several studies, and its clinical application is expanding.
- In patients with persistent atrial fibrillation, can the addition of posterior wall isolation (PWI) following pulmonary vein isolation (PVI) using PFA reduce recurrence?
Participants will:
- Undergo either PVI alone or PVI with additional left atrial posterior wall isolation (PWI)
- Visit the clinic to assess for recurrence of atrial tachyarrhythmias
Read the detailed description
Atrial fibrillation is a major cardiovascular disease, and catheter ablation has become an established rhythm-control strategy that provides superior outcomes compared with pharmacological therapy in patients with drug-refractory atrial fibrillation. Although the efficacy of pulmonary vein isolation (PVI) is well established in patients with paroxysmal atrial fibrillation, the effectiveness of additional ablation strategies beyond PVI remains uncertain in patients with persistent atrial fibrillation.
Several studies have suggested that left atrial posterior wall isolation (PWI) may help reduce recurrence; however, conventional thermal ablation techniques have been limited by technical challenges in achieving durable lesion formation. Pulsed field ablation (PFA) is a nonthermal ablation technology that creates selective myocardial lesions, enabling rapid and consistent lesion formation while minimizing injury to surrounding tissues.
This study aims to prospectively and randomly compare PVI alone using PFA with PVI followed by additional PWI in patients with persistent atrial fibrillation. By evaluating recurrence rates, procedure time, complications, atrial fibrillation burden, and patient satisfaction, this study seeks to identify the optimal ablation strategy for patients with persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulmonary Vein Isolation, Additional Left Atrial Posterior Wall Ablation, Non-PV trigger test
- Keywords
- pulsed field ablation, catheter ablation, posterior wall isolation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein IsolationProcedure or surgery
Also called PVI
- Pulmonary vein isolation (PVI) is performed as the primary procedure.
- After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group.
- Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization.
Additional Left Atrial Posterior Wall AblationProcedure or surgery
Also called Posterior box isolation
- Additional left atrial posterior wall ablation is performed.
- Complete electrical isolation of the entire left atrial posterior wall is confirmed (posterior box lesion isolation must be achieved).
- Post-procedural rhythm monitoring follows the study protocol.
Non-PV trigger testProcedure or surgery
- If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed.
- Post-procedural rhythm monitoring follows the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Additional Left Atrial Posterior Wall Ablation Group | Active comparator | Pulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo additional left atrial posterior wall isolation using pulsed field ablation. Before completion of the procedure, electrical isolation of both the pulmonary veins and the left atrial posterior wall will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol. Receives: Procedure: Pulmonary Vein Isolation; Procedure: Additional Left Atrial Posterior Wall Ablation |
| Pulmonary Vein Isolation (PVI) only Group | Placebo comparator | Pulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo no additional left atrial posterior wall isolation. Before completion of the procedure, electrical isolation of the pulmonary veins will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol. Receives: Procedure: Pulmonary Vein Isolation; Procedure: Non-PV trigger test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial tachyarrhythmia
Freedom from documented AF/AT/AFL ≥30 seconds at 12 months post-procedure
Measured: Within 12 months after the procedure, excluding the first 4-week blanking period
Secondary outcomes (5)
Peri-procedural complication
Major ; brain hemorrhage, thromboembolism , atrial -esophageal fistula, pericardial effusion, tamponade, irreversible phrenic nerve palsy, bleeding requiring transfusion, Pulmonary Vein Stenosis: Minor ; puncture site bleeding not requiring transfusion , groin hematoma, reversible phrenic nerve palsy
Measured: Within 12 months after the procedure
Total procedure time
total procedure time
Measured: Periprocedural
Length of hospital stay
Length of hospital stay
Measured: Within one year from the time of enrollment
Atrial fibrillation burden assessed by Holter ECG
Atrial fibrillation burden will be calculated as the percentage of the total analyzable Holter ECG monitoring time spent in atrial fibrillation or atrial tachyarrhythmia. Values range from 0% to 100%, with higher percentages indicating a greater atrial fibrillation burden and therefore a worse outcome.
Measured: Within 12 month from the time of enrollment
patient satisfaction
Atrial Fibrillation Effect on Quality-of-Life(AFEQT)
Measured: Within one year from the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start3 Jul 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Pulmonary vein isolation (PVI) is performed using pulsed-field ablation. After the procedure, electrical cardioversion is performed, and patients successfully converted to sinus rhythm are randomly assigned in a 1:1 ratio to either the PVI-only group or the PVI with additional left atrial posterior wall isolation group. 2. Patients who fail to convert to sinus rhythm after electrical cardioversion are excluded from randomization. 3. The target sample size is 482 patients, with 241 patients in each group. 4. Rhythm follow-up is performed at baseline, 3 months, 6 months, and 12 months using Holter monitoring or single-lead wearable ECG together with 12-lead ECG, with additional assessments when clinically indicated. 5. Outcomes include comparison of atrial tachyarrhythmia recurrence, procedural complications, procedure time, AF burden, and patient-reported satisfaction (AFEQT) between groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ewha Womans University Seoul Hospital, Korea University Anam Hospital, Kangbuk Samsung Hospital, Asan Medical Center, Severance Hospital, Samsung Medical Center, Chonnam National University Hospital, Daegu Catholic University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929897
- Sponsor's protocol ID
- POBI-PFA
- Acronym
- POBI-PFA
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and the lack of specific consent for data sharing obtained during the study enrollment process.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation With Posterior Wall Isolation for Pulse-Field Ablation in Persistent Atrial Fibrillation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06929897
- Acronym / sponsor ID
- POBI-PFA / POBI-PFA
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- pulsed field ablation, catheter ablation, posterior wall isolation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Ewha Womans University Seoul Hospital, Korea University Anam Hospital, Kangbuk Samsung Hospital, Asan Medical Center, Severance Hospital, Samsung Medical Center, Chonnam National University Hospital, Daegu Catholic University Medical Center
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Apr 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 date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in several studies, and its clinical application is expanding.
- In patients with persistent atrial fibrillation, can the addition of posterior wall isolation (PWI) following pulmonary vein isolation (PVI) using PFA reduce recurrence?
Participants will:
- Undergo either PVI alone or PVI with additional left atrial posterior wall isolation (PWI)
- Visit the clinic to assess for recurrence of atrial tachyarrhythmias
Detailed description
Atrial fibrillation is a major cardiovascular disease, and catheter ablation has become an established rhythm-control strategy that provides superior outcomes compared with pharmacological therapy in patients with drug-refractory atrial fibrillation. Although the efficacy of pulmonary vein isolation (PVI) is well established in patients with paroxysmal atrial fibrillation, the effectiveness of additional ablation strategies beyond PVI remains uncertain in patients with persistent atrial fibrillation.
Several studies have suggested that left atrial posterior wall isolation (PWI) may help reduce recurrence; however, conventional thermal ablation techniques have been limited by technical challenges in achieving durable lesion formation. Pulsed field ablation (PFA) is a nonthermal ablation technology that creates selective myocardial lesions, enabling rapid and consistent lesion formation while minimizing injury to surrounding tissues.
This study aims to prospectively and randomly compare PVI alone using PFA with PVI followed by additional PWI in patients with persistent atrial fibrillation. By evaluating recurrence rates, procedure time, complications, atrial fibrillation burden, and patient satisfaction, this study seeks to identify the optimal ablation strategy for patients with persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Pulmonary vein isolation (PVI) is performed using pulsed-field ablation. After the procedure, electrical cardioversion is performed, and patients successfully converted to sinus rhythm are randomly assigned in a 1:1 ratio to either the PVI-only group or the PVI with additional left atrial posterior wall isolation group. 2. Patients who fail to convert to sinus rhythm after electrical cardioversion are excluded from randomization. 3. The target sample size is 482 patients, with 241 patients in each group. 4. Rhythm follow-up is performed at baseline, 3 months, 6 months, and 12 months using Holter monitoring or single-lead wearable ECG together with 12-lead ECG, with additional assessments when clinically indicated. 5. Outcomes include comparison of atrial tachyarrhythmia recurrence, procedural complications, procedure time, AF burden, and patient-reported satisfaction (AFEQT) between groups.
| Arm | Type | Receives |
|---|---|---|
| Additional Left Atrial Posterior Wall Ablation Group | Active comparator | Procedure: Pulmonary Vein Isolation, Procedure: Additional Left Atrial Posterior Wall AblationPulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo additional left atrial posterior wall isolation using pulsed field ablation. Before completion of the procedure, electrical isolation of both the pulmonary veins and the left atrial posterior wall will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol. |
| Pulmonary Vein Isolation (PVI) only Group | Placebo comparator | Procedure: Pulmonary Vein Isolation, Procedure: Non-PV trigger testPulmonary vein isolation (PVI) is performed as the primary procedure. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo no additional left atrial posterior wall isolation. Before completion of the procedure, electrical isolation of the pulmonary veins will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 20 to 80 years who are candidates for catheter ablation for persistent atrial fibrillation
- Patients eligible for catheter ablation according to existing clinical guidelines
- Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)
- Those without contraindications to anticoagulation therapy
Key exclusion criteria (13 listed)
- Atrial fibrillation associated with severe congenital heart disease or structural heart disease
- Patients with contraindications to general anesthesia or sedation for the procedure
- History of prior cardiac surgery (e.g., Maze procedure, coronary artery bypass grafting)
- History of atrial fibrillation catheter ablation within the past 12 months
- Patients with severe left ventricular dysfunction (left ventricular ejection fraction <30%)
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 |
|---|---|---|
| Pulmonary Vein IsolationAlso: PVI1. Pulmonary vein isolation (PVI) is performed as the primary procedure. 2. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. 3. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. | Procedure or surgery | Additional Left Atrial Posterior Wall Ablation Group, Pulmonary Vein Isolation (PVI) only Group |
| Additional Left Atrial Posterior Wall AblationAlso: Posterior box isolation1. Additional left atrial posterior wall ablation is performed. 2. Complete electrical isolation of the entire left atrial posterior wall is confirmed (posterior box lesion isolation must be achieved). 3. Post-procedural rhythm monitoring follows the study protocol. | Procedure or surgery | Additional Left Atrial Posterior Wall Ablation Group |
| Non-PV trigger test1. If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed. 2. Post-procedural rhythm monitoring follows the study protocol. | Procedure or surgery | Pulmonary Vein Isolation (PVI) only Group |
Primary outcome
Recurrence of atrial tachyarrhythmia
Time frame: Within 12 months after the procedure, excluding the first 4-week blanking period
Freedom from documented AF/AT/AFL ≥30 seconds at 12 months post-procedure
5 secondary outcomes
Peri-procedural complication
Time frame: Within 12 months after the procedure
Total procedure time
Time frame: Periprocedural
Length of hospital stay
Time frame: Within one year from the time of enrollment
Atrial fibrillation burden assessed by Holter ECG
Time frame: Within 12 month from the time of enrollment
patient satisfaction
Time frame: Within one year from the time of enrollment
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 16 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and the lack of specific consent for data sharing obtained during the study enrollment process.
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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 Pulmonary Vein Isolation, Additional Left Atrial Posterior Wall Ablation and Non-PV trigger test in people with Atrial Fibrillation (AF), run by Ewha Womans University Mokdong Hospital 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 4 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 16 Jul 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. Some participants in this study may receive a placebo. 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 tachyarrhythmia (time frame: Within 12 months after the procedure, excluding the first 4-week blanking period). 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 16 Jul 2026.