Multicenter Randomized Controlled Study on Efficacy and Safety of Pulmonary Vein Isolation,Left Atrial Posterior Wall Ablation and Superior Vena Cava Isolation Using Pulsed Field Ablation for Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 436
- Locations
- 1
- Primary Endpoint
- Surgical success rate
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice, and there are more than 20 million AF patients in my country. Currently, rhythm control has become the main treatment option for AF, but there is still controversy over the best ablation procedure, especially whether other auxiliary ablation lines need to be added. Based on the existing clinical evidence, the durability and permeability of ablation damage are the main reasons for the differences. Pulsed electric field is a new ablation energy source based on the principle of cell electroporation. It has the characteristics of damage safety and permeability, so it is expected to solve the above dilemma. The study was divided into PVI (PVI-only) group according to the ratio of 1: 1, PVI + PWI + SVCI (posterior left atrial wall isolation and superior vena cava isolation) group. Through one-year follow-up of two groups of patients, the role of left atrial posterior wall and superior vena cava in the maintenance mechanism of persistent atrial fibrillation was explored, and the safety and effectiveness of domestic pulse ablation system were verified, which provided intellectual support for further medical and engineering integration
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years old and above, regardless of gender;
- •Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years);
- •Agree to participate in the study and be able and willing to comply with all follow-up requirements;-
Exclusion Criteria
- •Left ventricular ejection fraction (LVEF) ≤ 35%
- •Left atrial diameter (echocardiography) ≥ 55mm
- •Patients with a definite thrombus in the left atrium or a definite thrombus in the heart before surgery
- •Patients with cardiac function classification (NYHA) III-IV
- •Patients with second-degree (type II) or third-degree atrioventricular block
- •Persons with obvious congenital heart defects (such as atrial septal defect or severe pulmonary vein stenosis, but excluding patent foramen ovale)
- •Patients with prosthetic valve implantation
- •Patients with implanted cardiac pacemaker or cardiac defibrillator (ICD)
- •Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, myxoma
- •Patients with preoperatively known symptomatic carotid stenosis
Outcomes
Primary Outcomes
Surgical success rate
Time Frame: 12 months after surgery.
Surgical success rate: Except for the blank period, there was no recurrence of atrial arrhythmia ≥30s within 12 months after surgery.