Clinical trial NCT06671197: Study on the Ablation of Persistent Atrial Fibrillation Using Pulsed Electric Fields Under Different Surgical Procedures
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Persistent Atrial Fibrillation
Keywords: Pulsed Field Ablation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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 criteria: 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 outcomes:
measure: Surgical success rate
timeFrame: 12 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd
state: Sichuan
Study officials:
References: