Clinical trial NCT05400928: The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)
Official title: The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Pulsed Field Ablation
Paroxysmal
Ablation
Atrial fibrillation
ring-shaped ablation catheter
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Jiangxi Provincial People's Hopital
name: Second Affiliated Hospital of Guangzhou Medical University
name: Central South University
name: Second Affiliated Hospital of Nanchang University
name: Zhongshan Hospital Xiamen University
name: The First Affiliated Hospital of Dalian Medical University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2022-06-02
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Immediate success rate
timeFrame: during procedure
Secondary outcomes:
measure: Procedural success rate at 12 months after procedure
timeFrame: between 3 months and 12 months after ablation
measure: The occurrence of hospitalizations or emergency department visit due to symptoms of atrial arrhythmia at 6-month and 12-month follow-up
timeFrame: at 6-month and 12-month
measure: Evaluation of pulsed electric field ablation instrument
timeFrame: baseline
measure: Evaluation of a disposable cardiac pulsed electric field ablation catheter
timeFrame: baseline
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital Wuhan, Hubei China
name: Daowen Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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