The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)-A Prospective Multicenter Single-arm Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paroxysmal Atrial Fibrillation
- Sponsor
- Tongji Hospital
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Immediate success rate
- Last Updated
- 3 years ago
Overview
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
Investigators
Dao Wen Wang
Professor
Tongji Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Immediate success rate
Time Frame: during procedure
Procedural success for PAF is defined as the achievement of complete pulmonary venous electrical isolation
Secondary Outcomes
- Procedural success rate at 12 months after procedure(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)
- Evaluation of a disposable cardiac pulsed electric field ablation catheter(baseline)
- Evaluation of pulsed electric field ablation instrument(baseline)