NCT06671197Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 436 (estimated)
First submitted: 27 Sept 2024
Start date: 31 Mar 2025
Primary completion date: 31 Mar 2027
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Diseases: Atrial fibrillation
NCT number: NCT06671197

What you commit to

Study type: Observational
Planned participants: 436
From 31 Mar 2025 to the primary completion date, 31 Mar 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Lab values

Left ventricular ejection fraction (LVEF) ≤ 35%

Other

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 -

Who the study is looking for

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;-

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd Coordinator of this site? Confirm its status	Chengdu	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.