Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 28
- 主要终点
- Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
详细描述
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months.
The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of non-paroxysmal AF (persistent or longstanding persistent)
- •Concomitant indication for non-emergent open-heart surgery, eg,
- •Coronary artery bypass grafting
- •Valve repair or replacement
- •Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)
排除标准
- •Wolff-Parkinson-White syndrome
- •New York Heart Association (NYHA) Class = IV
- •Left Ventricular Ejection Fraction ≤ 30%
- •Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
- •Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure
- •Contraindication for anticoagulation therapy
- •Left atrial diameter > 6.0 cm
- •Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- •Renal failure requiring dialysis or hepatic failure
- •Life expectancy of less than 1 year
- •Predicted risk of operative mortality >10% as assessed by STS Risk Calculator
- •Pregnancy or desire to be pregnant within 12 months of the study treatment
- •Current diagnosis of active systemic infection
- •Active endocarditis
- •Documented MI 30 days prior to study enrollment
- •Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias
研究组 & 干预措施
Primary Cohort
Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
干预措施: Surgical Ablation (Procedure)
Primary Cohort
Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
干预措施: Cardioblate and Cryoflex hand held devices (Device)
结局指标
主要结局
Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
时间窗: 6-months post-procedure to 12-months post-procedure
Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.
Composite acute major adverse event rate
时间窗: 30-days post-procedure or hospital discharge (whichever is longer)
Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.
次要结局
- Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)(12-months post-procedure)
- Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)(6-months post-procedure)
- Percentage of new permanent pacemaker implantation (Safety)(12-months post-procedure)
- Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)(6-months post-procedure)
- Percentage of new permanent pacemaker implantation (Safety)(12-months post-procedure)
- Acute procedural success (Efficacy)(During index procedure)
- Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)(6-months post-procedure)
- Composite acute major adverse event rate (Safety)(12-months post-procedure)
- Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)(6-months post-procedure)
- Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)(12-months post-procedure)
- Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Quality of Life Score over time (Efficacy)(12-months post-procedure)
- SF-12 Health Survey (SF-12) Quality of Life Score over time (Efficacy)(12-months post-procedure)
- Composite acute major adverse event rate (Safety)(6-months post-procedure)