The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

Study Overview
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Brief Summary
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This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)

Detailed Description
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This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. For those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (Sichuan Jinjiang Electronic Technology Co., Ltd. Chengdu, China). The safety and efficacy of pulsed field ablation(PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) will be studied using ring-shaped pulsed field ablation catheter

Official Title
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The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Pulsed Field Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal Atrial Fibrillation (PAF) Exclusion Criteria: A history of atrial fibrillation ablation; Left ventricular ejectfraction(LVEF)<35% Left Atrium(LA)（echocardiography）>55mm Thrombus in the left atrial or heart before surgery New York Heart Association(NYHA) grade Ⅲ-Ⅳ second or third degree atrioventricular block Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale) Prosthetic valves Pacemakers or defibrillators (ICD) Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma Symptomatic carotid stenosis Untreated or uncontrolled hyperthyroidism or hypothyroidism Systemic active infection Renal failure with obvious bleeding tendency or undergoing hemodialysis Myocardial infarction or any cardiac intervention/open surgery within 3 months Stroke or transient ischemic attack within 6 months Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation Pregnant or lactating women or those who planned to have a family during the study period Have participated in clinical trials of other drugs or medical devices within 3 months Unsuitable to participate in this clinical trial by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-dimensional Directed Pulsed Field Ablation<br>Paroxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system | Device: Pulsed Field Ablation<br>* pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate success rate | Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate at 12 months after procedure | Procedural success for PAF was defined as the absence of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥30s) without antiarrhythmic drugs between 3 months and 12 months after ablation | between 3 months and 12 months after ablation | 
| The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up | The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up | at 6-month and 12-month | 
| Evaluation of pulsed electric field ablation instrument | operational stability; Hardware Connection validity; Software operability; degree of satisfaction | baseline | 
| Evaluation of a disposable cardiac pulsed electric field ablation catheter | Whether the catheter can reach its desired location smoothly; X ray and shadow;development is clear; Whether the conduit bend is adjustable; Whether the electrophysiological signal is clear and stable; When used together with the mapping system, whether mapping and 3D modeling can be carried out; When used in conjunction with the mapping system, can the catheter be located; Is it possible to stimulate normally; Whether the ablation can be performed normally; Were there any blood clots after withdrawal; Is the tube body intact after withdrawal from the body; Surgeon satisfaction | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsed Field Ablation, Paroxysmal, Ablation, Atrial fibrillation, ring-shaped ablation catheter