Paroxysmal Atrial Fibrillation
Conditions
Keywords
Pulsed Field Ablation, Paroxysmal, Ablation, Atrial fibrillation, ring-shaped ablation catheter
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
Interventions
DEVICEPulsed Field Ablation
pulmonary vein isolation will be performed with ring-shaped pulsed field ablation catheter directed by integrated three-dimensional mapping system
Sponsors
Jiangxi Provincial People's Hopital
Second Affiliated Hospital of Guangzhou Medical University
Central South University
Second Affiliated Hospital of Nanchang University
Zhongshan Hospital Xiamen University
The First Affiliated Hospital of Dalian Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate success rate | during procedure | Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 pulsed electric field ablation instrument | baseline | operational stability; Hardware Connection validity; Software operability; degree of satisfaction |
| 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 |
Countries
China
Contacts
Primary ContactDaowen Wang, PhD
Backup ContactYan Wang, PhD
Outcome results
None listed