Recording for Potential AF Drivers and Patient Specific Atrial Anatomy and Atrial Electrogram Maps Using an FDA Approved 64-Pole Basket Catheter (CONFIRM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Percentage of Drivers in Right Atrial
研究概览
简要总结
The 64 pole basket catheter used for the mapping procedure will be defined "atypical" sites which sustain atrial fibrillation. The ablation through the driver will lead to more rapid ablation of the atrial fibrillation.
详细描述
Atrial fibrillation (AF) is a common abnormal and rapid heart rhythm characterized by erratic electrical activity of the upper chambers of the heart. This cardiac arrhythmia may lead to stroke, heart failure, low blood pressure, chest pain, and increased mortality rate. Treatment may include medication to stop the rhythm abnormality, blood thinners, and/or ablation. Ablation involves application of heat or freezing to the area sustaining the rhythm abnormality. This requires tubes (catheters)to be placed in the heart. Human atrial fibrillation may be sustained by localized drivers (rapid and/or organized sites of atrial electrical activation). By mapping/recording the patient's specific atrial anatomy and atrial electrical activity with the 64-pole basket catheter, we may add to the knowledge base of these driver locations. We may also add to the knowledge about where best to ablate to terminate the arrhythmia. Typical anatomic
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at VCU Medical Center who are 21 years or older undergoing EPS for ablation of persistent AF (non-rheumatic) whose AF episodes last equal to or greater than 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
- •Per current standard of care, AF patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.
排除标准
- •Active coronary ischemic in the past year
- •Rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk
- •Prior ablation or cardiac surgery, that alters atrial electophysiology
- •Left atrial clot or dense contrast on TEE, which would increase thromboembolic risk
- •Out of range serum electrolytes, including K outside 4.0-5.0 mmol/1
- •Left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm
- •Thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
- •Pregnancy
- •Inability or unwillingness to provide informed consent
- •Unable to converse in English
- •Use of anti-arrhythmic drug less than 5 X half-life Prior ablation or cardiac surgery, that alters atrial electophysiology
结局指标
主要结局
Percentage of Drivers in Right Atrial
时间窗: 30 min
To determine where atypical areas of drivers might be.
Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources
时间窗: 30 minutes
percentage of patients
Time to Ablation of All Sources
时间窗: 30 minutes
total time taken to ablate all sources of rotors/focal sources in driver locations
Average Number of Rotors/Focal Drivers in Diverse Locations
时间窗: 30 minutes
次要结局
- Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs(30 min)
- Single-procedure Freedom From Atrial Fibrillation(one year)
- Mean Time to Recurrence of Atrial Fibrillation(1 year)
- Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation(1 year)