跳至主要内容
临床试验/NCT07601763
NCT07601763招募中不适用

Pulsed Field Ablation for Atrial Fibrillation Including Posterior Wall and Linear Ablation: A Randomized Controlled Trial of Safety and Efficacy (POWER-AF)

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 1,574 人开始时间: 2025年4月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,574
试验地点
1

研究概览

简要总结

Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. As of 2019, there were approximately 59.7 million patients with AF worldwide, including atrial flutter (AF). Atrial fibrillation can significantly increase the risks of stroke, thromboembolism and heart failure in patients, seriously affecting their quality of life.

Catheter ablation is the main means for rhythm control in patients with atrial fibrillation. A large number of clinical studies have confirmed the effectiveness and safety of catheter ablation for atrial fibrillation. It is significantly superior to drug treatment in maintaining sinus rhythm and can significantly improve symptoms and quality of life.

Pulsed electric field ablation (PFA) is a novel ablation method that utilizes pulsed electric fields as energy. It uses multiple short-duration and high-voltage electrical pulses to release ablation energy, selectively causing myocardial cells to rupture and die. However, it has no obvious damaging effect on blood vessels, nerves, and tissues around the heart, such as the lungs, esophagus, and phrenic nerve.

This trial was designed based on the advantage of the characteristic that PFA does not damage the esophagus, confining the damage to the posterior half of the left atrium and the circumferential isthmus of the mitral valve. While improving the ablation success rate, it is possible to protect the function of the left atrium. This study aims to verify the superiority of the new rhythm control strategy in a large-scale population by launching a prospective randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Atrial fibrillation patients who will accept catheter ablation.
  • Be capable of understanding and signing the informed consent form.

排除标准

  • Have contraindications for catheter ablation (such as atrial thrombosis, decompensated heart failure, etc.)
  • Have accepted catheter ablation before.
  • Myocardial infarction, or any cardiac interventional/surgery has been performed within 3 months.
  • Had a stroke or transient ischemic attack within 6 months.
  • Allergy to iodine contrast agents.
  • Participate in clinical trials related to other drugs or devices.
  • Pregnant women, lactating women, or women with plans to become pregnant shortly.
  • Active stage of infection.
  • Secondary atrial fibrillation, such as combined with rheumatic heart disease, hypertrophic cardiomyopathy, etc.
  • Patients who do not agree to be enrolled or are unable to cooperate to complete the study

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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