🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06671197
Starting soon Observational

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

NCT06671197 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2025-03-31
Last updated
2025-03-14

Condition(s) studied

Persistent Atrial Fibrillation

Investigational drug(s) / intervention(s)

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

Pulmonary vein isolation: Pulsed field ablation

Pulmonary vein isolation+posterior left atrial wall line+superior vena cava isolation: Pulsed field ablation

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 -

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd Chengdu Sichuan

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06671197 on ClinicalTrials.gov ↗ ← All trials in China