The Dynamics of Human Atrial Fibrillation
概览
- 阶段
- 不适用
- 干预措施
- Patients Undergoing Clinically-Indicated Maze Surgery
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Stanford University
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Does the Area of Organized Regions in AF predict success from Ablation?
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
Atrial fibrillation (AF) is an enormous public health problem in the United States, affecting 2-5 million Americans and causing rapid heart beats, stroke, heart failure or death. In this project, the applicant will develop a novel framework to better understand human AF that builds on agreement between several concepts for the disease. The applicant will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.
详细描述
The specific aim of this clinical study is to identify patients who will or will not respond to PVI, PVI plus other ablation or Maze surgery based on locations of organized-to-disorganized areas and clinical profile. We will develop non-invasive ECGI and intracardiac recordings in our registry, then test them prospectively in an observational study. Premise: Identifying responders or non-responders to PVI alone, or PVI plus other ablation or Maze surgery may enable patient-tailored therapy. This may raise overall success, reduce risks from unsuccessful procedures and improve resource utilization(58,128-130). This proposal will prospectively test in single-arm observations studies if patients who exhibit large organized AF areas at planned ablation regions have higher procedural success than patients with smaller areas. We will use non-invasive ECGI indices of organized AF, based on Preliminary data(9, 84, 85). This project is significant because it will establish a deeper understanding of AF and will develop strategies to identify AF patients who will best respond to each of several therapies, to guide personalized therapy.
研究者
Anson M Lee
Associate Professor of Cardiothoracic Surgery
Stanford University
入排标准
入选标准
- •referred for ablation or Maze surgery at Stanford Medicine for persistent AF (i.e. which requires cardioversion to terminate and/or lasts \>7 days)
- •Per our clinical practice and guidelines (Calkins et al., Heart Rhythm 2018), patients will have failed or be intolerant of \>or= 1 anti-arrhythmic drug. Patients after Maze surgery typically have failed prior endocardial ablation.
排除标准
- •active coronary ischemia or decompensated heart failure
- •atrial or ventricular clot on trans-esophageal echocardiography
- •pregnancy (to minimize fluoroscopic exposure)
- •inability or unwillingness to provide informed consent
- •rheumatic valve disease (results in a unique AF phenotype)
- •thrombotic disease or venous filters
- •prior chest surgery is a relative contraindication for Maze surgery
研究组 & 干预措施
Patients Undergoing Clinically-Indicated Maze Surgery
This group includes patients with persistent AF who will be undergoing clinically-indicated Maze surgery.
Patients Undergoing Clinically-Indicated Ablation
This groups includes patients with persistent AF who will be undergoing clinically-indicated ablation.
结局指标
主要结局
Does the Area of Organized Regions in AF predict success from Ablation?
时间窗: 1 year.
We will map areas of organized activity in all patients. We will compare if patients with success from ablation (absence of recurrent AF or atrial tachycardia on outpatient monitoring) have larger organized areas than those without success.
次要结局
- Does ablation through larger organized areas explain success from ablation.(1 year)