NCT07313228

Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion

Pulsed Field Ablation of Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion: A Prospective, Single-center, Single-arm Clinical Trial

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: First Affiliated Hospital of Ningbo University · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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). 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.

Conditions

• Atrial Fibrillation
• Left Atrial Appendage Occlusion
• Pulsed Field Ablation

Interventions

Type	Name	Description
PROCEDURE	Pulsed Field Ablation	Pulsed Field Ablation is a surgical technique for atrial fibrillation ablation that uses pulsed electric fields.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-12-31
• Last updated: 2025-12-31