Vision-MR Ablation Catheter 2.0 for the Treatment of Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy 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
- •Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)
- •Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure
- •Diagnosis of Ischemic Cardiomyopathy
- •AAD therapy refractory, contraindicated, not tolerated, or not desired
- •18 years or older
排除标准
- •Implanted with non-MR compatible medical devices or contraindicated for an MRI
- •Presence of intracardiac thrombus (verified via CT/MRI/TEE/TTE within 48 hours of procedure - or at start of procedure)
- •Thrombocytopenia or coagulopathy
- •Mechanical mitral and/or aortic valve precluding access to the left ventricle
- •Severe aortic stenosis
- •Myocardial infarction requiring stent implantation within 90 days of procedure
- •Previous cardiac surgery within 60 days of procedures
- •Known/uncontrolled stroke risks
- •Class IV Heart Failure
- •Ejection Fraction (EF) < 25%
- •Patients with a glomerular filtration rate (GFR) < 30
- •Women who are pregnant
- •Allergy to contrast agents (e.g., Gadolinium)
- •Active infection
- •Known or suspected myxoma
- •Unstable angina
- •Patients who do not tolerate anticoagulation therapy
- •Previous intertribal septal patch or prosthetic atrial septal defect closure device
- •Life expectancy < 12 months
- •Enrollment in another study without sponsor approval
研究组 & 干预措施
Non-Randomized
All subjects with ventricular tachycardia associated with ischemic cardiomyopathy will undergo catheter ablation using the Vision-MR Ablation Catheter 2.0
干预措施: Vision-MR Ablation Catheter 2.0 (Device)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: Perioperative/Periprocedural
Absence of inducible clinical ventricular tachycardia (VT) following the last RF application with with the Vision-MR Ablation Catheter 2.0
Primary Safety Endpoint
时间窗: 7 days
Composite of any procedure or device related serious adverse events through 7 days post index ablation procedure
次要结局
- Secondary Efficacy Endpoint(6 months)