Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 72
- 主要终点
- Chronic Success Rate
研究概览
简要总结
The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
详细描述
The ZERO-AF trial is a prospective, multicenter, single blind, 1:1 randomized study. The trial is designed to demonstrate that the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter are non-inferior to the safety and effectiveness of the control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. The control catheters are open-irrigated radiofrequency ablation catheters that are approved in the United States for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
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
- 否
入选标准
- •History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days prior to enrollment
- •o PAF is AF episodes that last ≥30 seconds in duration and terminate within 7 days.
- •At least 1 episode of PAF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG in the 365 days prior to enrollment
- •Refractory to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD)
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation
排除标准
- •Have any of the following heart conditions within 90 days prior to enrollment:
- •New York Heart Association (NYHA) Class III or IV
- •Left ventricular ejection fraction (LVEF) <35%
- •Left atrial (LA) diameter >5.5 cm
- •Unstable angina or ongoing myocardial ischemia
- •Transmural myocardial infarction (MI)
- •Congenital structural heart disease that increases the risk of ablation or precludes catheter placement
- •Undergone any left atrial catheter or surgical ablation
- •Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment
- •Had >1 AF episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year
- •Subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment
- •Contraindication to anticoagulation therapy
- •Creatinine >2.5mg/dl or creatinine clearance <30mL/min within 90 days (3 months) prior to enrollment
- •Prosthetic mitral or tricuspid heart valves
- •Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment
- •Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment
- •History of CVA, TIA or PE within 180 days (6 months) prior to enrollment
- •Left atrial appendage closure device
- •Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD)
- •Enrolled in any concurrent clinical trial without documented pre-approval from BSC
- •Women who are pregnant or plan to become pregnant within the course of their participation in the investigation
- •Life expectancy ≤ 2 years (730 days) per physician opinion
结局指标
主要结局
Chronic Success Rate
时间窗: Within 12 months of the index procedure
The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure\* in the investigational group is non-inferior to those in the control group. \*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.
Procedure-related Complication Free Rate
时间窗: 12 Months
The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group. The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.
次要结局
- Acute Success(Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation)