The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF) (ESPFA-CN21)

Tongji Hospital

Status: Unknown

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Pulsed Field Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05400928

JJETCT2021002

Details and patient eligibility

About

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

Full 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

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 1 patient group

Three-dimensional Directed Pulsed Field Ablation

Experimental group

Description:

Paroxysmal atrial fibrillation will be ablated with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system

Treatment:

Device: Pulsed Field Ablation