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

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Pulsed Field Ablation

• Registration Number: NCT05400928
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-07-05
• Study First Submitted: 2021-12-01
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Paroxysmal Atrial Fibrillation (PAF)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Three-dimensional Directed Pulsed Field Ablation	Pulsed Field Ablation	Paroxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system

Primary Outcome Measures

Name	Time	Method
Immediate success rate	during procedure	Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation

Secondary Outcome Measures

Name	Time	Method
Procedural success rate at 12 months after procedure	between 3 months and 12 months after ablation	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
The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up	at 6-month and 12-month	The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month of follow-up
Evaluation of a disposable cardiac pulsed electric field ablation catheter	baseline	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
Evaluation of pulsed electric field ablation instrument	baseline	operational stability; Hardware Connection validity; Software operability; degree of satisfaction

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China