Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 91
- 试验地点
- 6
- 主要终点
- Primary Efficacy Endpoint: Bi-directional block confirmation
研究概览
简要总结
The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
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
- •Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
- •Patient 18 years and older
排除标准
- •Contraindications for MRI procedures
- •Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure
- •Previous CTI ablation procedures
- •Myocardial infarction within 60 days of enrollment
- •Current unstable angina
- •Cardiac surgery within 90 days of enrollment
- •Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment
- •Thrombocytosis or thrombocytopenia
- •Contraindication to anticoagulation therapy
- •Currently documented intracardiac thrombus or myxoma
- •Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment
- •Prosthetic valve through which the catheter must pass
- •Interatrial baffle or patch through which the catheter must pass
- •Moderate or severe tricuspid valve regurgitation or stenosis
- •Uncompensated congestive heart failure
- •Active systemic infection
- •Pregnancy or if subject plans to become pregnant during the trial
- •Uncontrolled hyperthyroidism
- •Any other significant uncontrolled or unstable medical condition
- •Enrollment in any concurrent study without Imricor written approval
- •Life expectancy of less than or equal to 2 years (730 days) per physician opinion
研究组 & 干预措施
Vision-MR Atrial Flutter Ablation
Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.
干预措施: RF Ablation (Device)
结局指标
主要结局
Primary Efficacy Endpoint: Bi-directional block confirmation
时间窗: Time of procedure, following delivery of last ablation energy delivery point
Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator \& irrigation pump.
Primary Safety Endpoint: Composite of serious cardiovascular adverse events
时间窗: 7-days post procedure
A composite of the following serious adverse events as adjudicated by an independent clinical events committee: * Cardiac perforation/tamponade * Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Complete heart block * Myocardial infarction * Pulmonary embolism * MR-related serious adverse events * Unanticipated device related serious adverse events * Death
次要结局
- Chronic Safety Endpoint: all serious adverse event rate for duration of study(3 months (90 days))
- Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days(3 months (90 days))