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

Zhejiang University

Status

Not yet enrolling

Conditions

Persistent Atrial Fibrillation

Treatments

Device: Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation

Device: Pulmonary vein isolation

Study type

Observational

Funder types

Other

Identifiers

NCT06671197

20240926

Details and patient eligibility

About

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

Enrollment

436 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 -