Mapping Electrogram Morphology Recurrence for Atrial Fibrillation Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
研究概览
简要总结
The overall goal of this project is to test the feasibility of performing real-time electrogram morphology recurrence (EMR) mapping in patients with persistent atrial fibrillation (AF) to locate areas of high electrogram morphology recurrence rate. The Investigator believe that the EMR mapping can be integrated into cardiac mapping and used to identify potential sites for ablation. Furthermore, this study could help demonstrate the efficacy of this technology's ability to terminate or slow AF.
The Investigator will test this technology on ten subjects undergoing a second ablation procedure. The Investigator will map the AF utilizing the EMR to indicate locations of stable activity and ablate the area. The Investigator believes that the study could produce acute AF termination or AF cycle length slowing. In addition to testing the real-time electrogram morphology recurrence mapping, the study would also like to determine the acute effects of radiofrequency ablation of areas of high recurrence rates and determine long term freedom from AF following ablation of areas of high recurrence rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male and female at least 21 years of age
- •persistent Afib with one prior failed ablation for persistent or long standing persistent Afib
排除标准
- •Inability to sign consent
- •Patients with a life expectancy less than one (1) year
- •Patients with chronic kidney disease with sufficiently low GFR that precludes either CT angiogram of the heart or contrast MRI study
- •Pregnant women and women that are breast feeding
- •Patients with multiple (2 or more) prior failed ablations
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
结局指标
主要结局
Real-time Electrogram Morphology Recurrence (EMR) Mapping Feasibility
时间窗: 2 hours
As measured by number of patients where real-time EMR mapping is completed.
次要结局
- Number of Participants With Treatment Emergent Adverse Events(30 days)
- Ablation Acute Effects(2 hours)
研究者
Jeffrey Goldberger
Chief, Cardiovascular Division
University of Miami