Atrial FibrillationPFA after LAAONCT07313228
Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion
An observational study of Atrial Fibrillation and Left Atrial Appendage Occlusion, run by First Affiliated Hospital of Ningbo University.
Trial summary
This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Occlusion, Pulsed Field Ablation
- What is being tested?
- Pulsed Field Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2027
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: The selected population consists of adult patients with a documented history of atrial fibrillation who have undergone left atrial appendage occlusion and are planned to undergo pulsed field ablation due to ineffective drug treatment. Additionally, they must not have any surgical contraindications.
Who may be able to join
- Aged 18-75 years;
- Documented symptomatic atrial fibrillation;
- Ineffective or intolerant to at least one class I or III antiarrhythmic drug;
- Able to fully understand the treatment protocol, voluntarily sign the informed consent form, and willing to undergo the required examinations, procedures, and follow-up.
Who cannot join
- Patients who have previously undergone left atrial surgery;
- Left atrial thrombus;
- Patients with pulmonary agenesis;
- Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;
- Left atrial anteroposterior diameter ≥ 55 mm;
- Left ventricular ejection fraction (LVEF) ≤ 40%;
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- Patients who have previously undergone interatrial septal repair or removal of atrial myxoma;
- Patients with active implanted devices (e.g., pacemaker, ICD);
- Patients with NYHA heart failure class III-IV;
- Patients with a clear history of cerebrovascular disease (including cerebral hemorrhage, stroke, or TIA) within the past 6 months;
- Patients who have experienced cardiovascular events (e.g., acute myocardial infarction, coronary intervention or bypass surgery, valve replacement or repair, atrial or ventricular surgery) within the past 3 months;
- Patients with acute or severe systemic infections;
- Patients with severe liver or kidney disease, malignancy, or end-stage disease that may affect the treatment, assessment, or compliance of the trial (as judged by the investigator);
- Patients with significant bleeding tendency, hypercoagulable state, or severe hematologic disorders;
- Patients who have participated or are currently participating in another clinical trial within the past 12 months prior to enrollment;
- Patients who the investigator deems unsuitable for participation in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pulsed Field Ablation of Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion: A Prospective, Single-center, Single-arm Clinical Trial
This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). The trial will include patients who have undergone successful LAAO and have symptomatic AF that is refractory to or intolerant of class I or III antiarrhythmic drugs. The primary objective is to assess the effectiveness of PFA in preventing AF recurrence and its safety, including the occurrence of serious adverse events. Patients will be followed up for 12 months post-procedure to evaluate outcomes such as recurrence of AF, complications, and device-related issues.
Read the detailed description
This clinical trial aims to explore the safety and efficacy of pulsed field ablation (PFA) in patients who have undergone left atrial appendage occlusion (LAAO) for the treatment of non-valvular atrial fibrillation (AF). LAAO is an effective strategy for stroke prevention in patients with AF, and PFA is a novel non-thermal ablation technique that may offer advantages over traditional radiofrequency ablation, particularly by minimizing collateral damage to surrounding structures.
The study will enroll adult patients aged 18-75 years who have symptomatic AF that is refractory to or intolerant of at least one class I or III antiarrhythmic drug and have previously undergone LAAO. The trial will be conducted at a single center, with each participant receiving PFA after LAAO.
The procedure will involve the use of PFA to ablate the left atrium and achieve electrical isolation of the pulmonary veins, guided by fluoroscopy and intracardiac echocardiography. The primary endpoint is the absence of any atrial arrhythmia (AF or atrial flutter) over a 12-month follow-up period, assessed via ECG and Holter monitoring. Secondary endpoints include acute procedural success (i.e., achieving pulmonary vein isolation), as well as the assessment of complications such as phrenic nerve injury, device-related issues, and other adverse events.
The study will monitor patients closely post-procedure at 24 hours, 1 month, 3 months, 6 months, and 12 months, assessing clinical outcomes such as recurrence of AF, device-related complications, and changes in the left atrial appendage closure device position or leak. Data from baseline evaluations, including echocardiography, CT, and blood tests, will be collected and used for comparative analysis throughout the study.
This research is expected to contribute valuable evidence on the feasibility, safety, and efficacy of combining LAAO with PFA in the treatment of non-valvular AF, potentially benefiting a large population of patients who have limited treatment options.
- Being tested
- Pulsed Field Ablation
- Keywords
- Atrial Fibrillation, left atrial appendage occlusion, pulsed field 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.
Pulsed Field AblationProcedure or surgery
Pulsed Field Ablation is a surgical technique for atrial fibrillation ablation that uses pulsed electric fields.
| Study group | Role | What they receive |
|---|---|---|
| PFA after LAAO group | The patients in this group have previously undergone Left Atrial Appendage Occlusion (LAAO) surgery and are scheduled to undergo Pulsed Field Ablation (PFA). The study will only collect comprehensive data throughout their treatment process without introducing any additional interventions. Receives: Procedure: Pulsed Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No recurrence of atrial arrhythmias within 12 months
Defined as the absence of such arrhythmias in the efficacy evaluation period (from blanking period to the end of 12-month follow-up) based on ECG data (including both surface ECG and 24-hour Holter monitoring).
Measured: 12month
Secondary outcomes (1)
Ablation success
Defined as the maintenance of electrical isolation of the pulmonary veins, regardless of whether isoproterenol is used, after programmed stimulation.
Measured: Instantly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313228
- Sponsor's protocol ID
- NBUFH-2025Y-289A
- Other IDs
- MR-33-25-078136
- Acronym
- PFA after LAAO
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.
PubMed 8572814Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
PubMed 29103847Osmancik P, Herman D, Neuzil P, Hala P, Taborsky M, Kala P, Poloczek M, Stasek J, Haman L, Branny M, Chovancik J, Cervinka P, Holy J, Kovarnik T, Zemanek D, Havranek S, Vancura V, Opatrny J, Peichl P, Tousek P, Lekesova V, Jarkovsky J, Novackova M, Benesova K, Widimsky P, Reddy VY; PRAGUE-17 Trial Investigators. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol. 2020 Jun 30;75(25):3122-3135. doi: 10.1016/j.jacc.2020.04.067.
PubMed 32586585Tam MTK, Kojodjojo P, Lam YY, Chow J, Wong C, Kam KK, Wong GLN, Chan CP, Chan JYS, So KC. Combined pulsed field ablation and left atrial appendage occlusion: A multicenter comparative study. Heart Rhythm. 2025 Oct;22(10):2579-2584. doi: 10.1016/j.hrthm.2025.03.1968. Epub 2025 Mar 21.
PubMed 40122196Beney J, Galea R, Siontis G, Grani C, Kueffer T, Brugger N, Reichlin T, Raber L, Roten L. Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage. Europace. 2024 Jul 2;26(7):euae176. doi: 10.1093/europace/euae176.
PubMed 38917059
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation of Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion: A Prospective, Single-center, Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07313228
- Acronym / sponsor ID
- PFA after LAAO / NBUFH-2025Y-289A
- Keywords
- Atrial Fibrillation, left atrial appendage occlusion, pulsed field ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). The trial will include patients who have undergone successful LAAO and have symptomatic AF that is refractory to or intolerant of class I or III antiarrhythmic drugs. The primary objective is to assess the effectiveness of PFA in preventing AF recurrence and its safety, including the occurrence of serious adverse events. Patients will be followed up for 12 months post-procedure to evaluate outcomes such as recurrence of AF, complications, and device-related issues.
Detailed description
This clinical trial aims to explore the safety and efficacy of pulsed field ablation (PFA) in patients who have undergone left atrial appendage occlusion (LAAO) for the treatment of non-valvular atrial fibrillation (AF). LAAO is an effective strategy for stroke prevention in patients with AF, and PFA is a novel non-thermal ablation technique that may offer advantages over traditional radiofrequency ablation, particularly by minimizing collateral damage to surrounding structures.
The study will enroll adult patients aged 18-75 years who have symptomatic AF that is refractory to or intolerant of at least one class I or III antiarrhythmic drug and have previously undergone LAAO. The trial will be conducted at a single center, with each participant receiving PFA after LAAO.
The procedure will involve the use of PFA to ablate the left atrium and achieve electrical isolation of the pulmonary veins, guided by fluoroscopy and intracardiac echocardiography. The primary endpoint is the absence of any atrial arrhythmia (AF or atrial flutter) over a 12-month follow-up period, assessed via ECG and Holter monitoring. Secondary endpoints include acute procedural success (i.e., achieving pulmonary vein isolation), as well as the assessment of complications such as phrenic nerve injury, device-related issues, and other adverse events.
The study will monitor patients closely post-procedure at 24 hours, 1 month, 3 months, 6 months, and 12 months, assessing clinical outcomes such as recurrence of AF, device-related complications, and changes in the left atrial appendage closure device position or leak. Data from baseline evaluations, including echocardiography, CT, and blood tests, will be collected and used for comparative analysis throughout the study.
This research is expected to contribute valuable evidence on the feasibility, safety, and efficacy of combining LAAO with PFA in the treatment of non-valvular AF, potentially benefiting a large population of patients who have limited treatment options.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFA after LAAO group | – | Procedure: Pulsed Field AblationThe patients in this group have previously undergone Left Atrial Appendage Occlusion (LAAO) surgery and are scheduled to undergo Pulsed Field Ablation (PFA). The study will only collect comprehensive data throughout their treatment process without introducing any additional interventions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The selected population consists of adult patients with a documented history of atrial fibrillation who have undergone left atrial appendage occlusion and are planned to undergo pulsed field ablation due to ineffective drug treatment. Additionally, they must not have any surgical contraindications.
Key inclusion criteria (4 listed)
- Aged 18-75 years;
- Documented symptomatic atrial fibrillation;
- Ineffective or intolerant to at least one class I or III antiarrhythmic drug;
- Able to fully understand the treatment protocol, voluntarily sign the informed consent form, and willing to undergo the required examinations, procedures, and follow-up.
Key exclusion criteria (16 listed)
- Patients who have previously undergone left atrial surgery;
- Left atrial thrombus;
- Patients with pulmonary agenesis;
- Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;
- Left atrial anteroposterior diameter ≥ 55 mm;
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 |
|---|---|---|
| Pulsed Field AblationPulsed Field Ablation is a surgical technique for atrial fibrillation ablation that uses pulsed electric fields. | Procedure or surgery | PFA after LAAO group |
Primary outcome
No recurrence of atrial arrhythmias within 12 months
Time frame: 12month
Defined as the absence of such arrhythmias in the efficacy evaluation period (from blanking period to the end of 12-month follow-up) based on ECG data (including both surface ECG and 24-hour Holter monitoring).
1 secondary outcome
Ablation success
Time frame: Instantly
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 31 Dec 2025.
- Background: PubMed 8572814Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.
- Background: PubMed 29103847Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
- Background: PubMed 32586585Osmancik P, Herman D, Neuzil P, Hala P, Taborsky M, Kala P, Poloczek M, Stasek J, Haman L, Branny M, Chovancik J, Cervinka P, Holy J, Kovarnik T, Zemanek D, Havranek S, Vancura V, Opatrny J, Peichl P, Tousek P, Lekesova V, Jarkovsky J, Novackova M, Benesova K, Widimsky P, Reddy VY; PRAGUE-17 Trial Investigators. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. J Am Coll Cardiol. 2020 Jun 30;75(25):3122-3135. doi: 10.1016/j.jacc.2020.04.067.
- Background: PubMed 40122196Tam MTK, Kojodjojo P, Lam YY, Chow J, Wong C, Kam KK, Wong GLN, Chan CP, Chan JYS, So KC. Combined pulsed field ablation and left atrial appendage occlusion: A multicenter comparative study. Heart Rhythm. 2025 Oct;22(10):2579-2584. doi: 10.1016/j.hrthm.2025.03.1968. Epub 2025 Mar 21.
- Background: PubMed 38917059Beney J, Galea R, Siontis G, Grani C, Kueffer T, Brugger N, Reichlin T, Raber L, Roten L. Feasibility study on atrial fibrillation ablation with pulsed field ablation and concomitant occlusion of the left atrial appendage. Europace. 2024 Jul 2;26(7):euae176. doi: 10.1093/europace/euae176.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Left Atrial Appendage Occlusion, run by First Affiliated Hospital of Ningbo University.
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 16 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jiedong Zhou, PhD (17816533346, 1552882461@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No recurrence of atrial arrhythmias within 12 months (time frame: 12month). 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 NCT07313228, which also lists 5 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 31 Dec 2025.