Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 27
- 主要终点
- Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
研究概览
简要总结
This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).
详细描述
The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.
The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit.
The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years; < 80 years
- •Left atrium < 6.0 cm
- •Refractory or intolerant to one AAD (class I and/or III)
- •Documentation of persistent AF
- •Provided written informed consent
排除标准
- •Patients requiring concomitant surgery
- •Left ventricular ejection fraction < 40%
- •Pregnant or planning to become pregnant during study
- •Co-morbid medical conditions that limit one year life expectancy
- •Previous cardiac surgery
- •History of pericarditis
- •Previous cerebrovascular accident (CVA), excluding fully resolved transient Ischemic attack (TIA)
- •Patients who have active infection or sepsis
- •Patients with esophageal ulcers strictures and varices
- •Patients with renal dysfunction who are not on dialysis
- •Patients who are contraindicated for anticoagulants
- •Patients who are being treated for ventricular arrhythmias
- •Patients who have had a previous left atrial catheter ablation for AF
- •Patients with existing Implantable Cardioverter-Defibrillator (ICDs)
- •Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- •Not competent to legally represent him or herself
研究组 & 干预措施
Convergent Procedure
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
干预措施: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax (Device)
Convergent Procedure
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
干预措施: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering (Device)
Standalone Endocardial Catheter Ablation
Procedure/Surgery: Endocardial Catheter Ablation Treatment
干预措施: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering (Device)
结局指标
主要结局
Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
时间窗: 12 Months
This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.
Primary Safety Analysis
时间窗: 30 days
The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure.
次要结局
- Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.(12 Months)
- Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)(12 Months)
- Change in Atrial Fibrillation Severity Scale (AFSS)(12 months)
- AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.(12 Months)
- Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.(12 month)
- Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline(12 Months)
- Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)(12 months)
- Change in 6-Minute Walk Score(12 months)
- Change in Left Atrial Diameter(6 Months)