Compares two pulsed field ablation approaches for persistent atrial fibrillation
Compares pulsed field ablation procedures in adults with persistent atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Study on the Ablation of Persistent Atrial Fibrillation Using Pulsed Electric Fields Under Different Surgical Procedures
Key facts
- Where
- Chengdu, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with persistent atrial fibrillation who still have symptoms despite medicines. It compares two ablation procedures that use pulsed electric fields.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Symptomatic persistent atrial fibrillation that did not respond to drugs, diagnosed within 3 years.
- Earlier treatment
- Medicines for atrial fibrillation did not work well enough. No heart intervention or open heart surgery in the last 3 months. No other drug or device trial in the last 3 months.
Main reasons for not taking part
- Left ventricular ejection fraction of 35% or lower
- Left atrium diameter of 55mm or more on echocardiography
- Known blood clot in the left atrium or heart before the procedure
- Pacemaker or defibrillator (ICD), or a prosthetic heart valve
- Stroke or transient ischemic attack in the last 6 months
Read by machine on 9 November 2026.
Where in China
- Sichuan Jinjiang Electronic Medical Device Technology Co., LtdChengdu, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT06671197
- Record updated
- 14 March 2025
- Original description
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 integrationRead full original descriptionShow less
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
Inclusion: 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: Patients with obvious contraindications to interventional surgery and who are judged by the investigator to be unable to undergo ablation surgery; Patients who have participated in clinical trials of other drugs or medical devices within 3 months; 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; Persons with obvious congenital heart defects (such as atrial septal defect or severe pulmonary vein stenosis, but excluding patent foramen ovale); Patients with implanted cardiac pacemaker or cardiac defibrillator (ICD); Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, myxoma; 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; Left ventricular ejection fraction (LVEF) ≤ 35%; Left atrial diameter (echocardiography) ≥ 55mm; Patients with second-degree (type II) or third-degree atrioventricular block; Patients with prosthetic valve implantation; Patients with preoperatively known symptomatic carotid stenosis; Patients with untreated or controlled hyperthyroidism or hypothyroidism; Women who are pregnant or breastfeeding or who have a family planning during the study period; Patients considered inappropriate by the investigator to participate in this clinical trial -.