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

NCT06671197 | Not Yet Recruiting

• 1 other identifier: 20240926
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Atrial Fibrillation

Keywords

Pulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

• Surgical success rate

  Surgical success rate: Except for the blank period, there was no recurrence of atrial arrhythmia ≥30s within 12 months after surgery.

  12 months after surgery.

Study Arms (2)

PVI-only

Device: Pulmonary vein isolation

PVI + PWI + SVCI

posterior left atrial wall isolation and superior vena cava isolation

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

Interventions

Pulmonary vein isolation DEVICE

Pulsed field ablation

PVI-only

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

Pulsed field ablation

PVI + PWI + SVCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;-

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Youqi FAN, Chief physician

CONTACT

+86 13867482684; fanyq@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: November 4, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CN (1)