Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion (PFA after LAAO)

December 17, 2025 updated by: First Affiliated Hospital of Ningbo University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Aged 18-75 years;
  2. Documented symptomatic atrial fibrillation;
  3. Ineffective or intolerant to at least one class I or III antiarrhythmic drug;
  4. Able to fully understand the treatment protocol, voluntarily sign the informed consent form, and willing to undergo the required examinations, procedures, and follow-up.

Exclusion Criteria:

  1. Patients who have previously undergone left atrial surgery;
  2. Left atrial thrombus;
  3. Patients with pulmonary agenesis;
  4. Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;
  5. Left atrial anteroposterior diameter ≥ 55 mm;
  6. Left ventricular ejection fraction (LVEF) ≤ 40%;
  7. Patients who have previously undergone interatrial septal repair or removal of atrial myxoma;
  8. Patients with active implanted devices (e.g., pacemaker, ICD);
  9. Patients with NYHA heart failure class III-IV;
  10. Patients with a clear history of cerebrovascular disease (including cerebral hemorrhage, stroke, or TIA) within the past 6 months;
  11. 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;
  12. Patients with acute or severe systemic infections;
  13. 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);
  14. Patients with significant bleeding tendency, hypercoagulable state, or severe hematologic disorders;
  15. Patients who have participated or are currently participating in another clinical trial within the past 12 months prior to enrollment;
  16. Patients who the investigator deems unsuitable for participation in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Pulsed Field Ablation
Pulsed Field Ablation is a surgical technique for atrial fibrillation ablation that uses pulsed electric fields.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation success
Time Frame: Instantly
Defined as the maintenance of electrical isolation of the pulmonary veins, regardless of whether isoproterenol is used, after programmed stimulation.
Instantly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Ningbo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBUFH-2025Y-289A
  • MR-33-25-078136 (Other Identifier: Medical Research Registration and Record Information System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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