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NCT Number: NCT06671197

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Jinjiang Electronic Medical Device Technology Co., Ltd

Chengdu, Sichuan, China

Location contact

XINlin Yang

CONTACT

[email protected]

15258090991

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Pulmonary vein isolation

Device

Pulsed field ablation

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

Device

Pulsed field ablation

Primary outcomes

  1. Surgical success rate

    Time frame: 12 months after surgery.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Youqi FAN, Chief physician

CONTACT

[email protected]

+86 13867482684

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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