Study on the Ablation of Persistent Atrial Fibrillation Using Pulsed Electric Fields Under Different Surgical Procedures

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Pulmonary vein isolation; Device: Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation

• Study Type: Observational
• Enrollment (Estimated): 436

Contacts and Locations

• Study Contact: Name: Youqi FAN, Chief physician; Phone Number: +86 13867482684; Email: fanyq@zju.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd
      • Contact: XINlin Yang; Phone Number: 15258090991; Email: 15258090991@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

1.18 years old and above, regardless of gender; 2.Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years); 3.Agree to participate in the study and be able and willing to comply with all follow-up requirements

Description

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
• Patients with untreated or controlled hyperthyroidism or hypothyroidism
• Patients with systemically active infections
• Patients with renal failure who have significant bleeding tendency or are undergoing hemodialysis
• Patients with myocardial infarction or any cardiac intervention/open surgery within 3 months
• Patients who have had a stroke or transient ischemic attack within 6 months
• Patients with obvious contraindications to interventional surgery and who are judged by the investigator to be unable to undergo ablation surgery
• Women who are pregnant or breastfeeding or who have a family planning during the study period
• Patients who have participated in clinical trials of other drugs or medical devices within 3 months
• Patients considered inappropriate by the investigator to participate in this clinical trial -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PVI-only	Device: Pulmonary vein isolation; Pulsed field ablation
PVI + PWI + SVCI; posterior left atrial wall isolation and superior vena cava isolation	Device: Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation; Pulsed field ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	Surgical success rate: Except for the blank period, there was no recurrence of atrial arrhythmia ≥30s within 12 months after surgery.	12 months after surgery.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Pulsed Field Ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20240926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No