NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 249
- 主要终点
- The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
研究概览
简要总结
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.
详细描述
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Documented spontaneous episodes of sustained ventricular tachycardia (must satisfy one)
- •For patients with ICDs: Documented episodes must be four (4) or greater for entry into the study.
- •For patients without ICDs: Documented episodes must be two (2) or greater within two (2) months and the assessment will be performed by a review of ECGs and hospitalization records.
- •Incessant VT due to prior myocardial infarction (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion).
- •Spontaneous occurrence of symptomatic ventricular tachycardia despite antiarrhythmic drug therapy or ICD intervention.
- •Left ventricular ejection fraction > 10% as estimated by echocardiography, contrast ventriculography or radionuclide imaging within the previous ninety (90) days.
- •Age eighteen (18) years or older.
- •Signed Patient Informed consent form.
- •Able and willing to comply with all pre-, post-, and follow-up testing requirements.
排除标准
- •Definite protruding left ventricular thrombus on pre-ablation echocardiogram.
- •Myocardial infarction within the preceding two (2) months. Patients with incessant VT (defined as present for more than one (1) hour and refractory to or immediately recurrent after administration of antiarrhythmic medication and cardioversion) may be enrolled if their MI is at least three (3) weeks old.
- •Patients with idiopathic VT.
- •Other disease process likely to limit survival to less than twelve (12) months.
- •Class IV heart failure.
- •Serum creatinine of > 2.5 mg/dl.
- •Thrombocytopenia (defined as platelet count <80,000) or coagulopathy.
- •Contraindication to heparin.
- •Women who are pregnant.
- •Cardiac surgery (i.e. ventriculotomy, atriotomy) within the past two (2) months. Patients with incessant VT (present 50% of the time with intervention for a period >12 h) may be enrolled if their surgery is at least three (3) weeks old.
- •Acute illness or active systemic infection.
- •Unstable angina.
- •Severe aortic stenosis or flail mitral valve.
- •Uncontrolled heart failure.
- •Significant congenital anomaly or medical problem that, in the opinion of the Principal Investigator, would preclude enrollment in the study.
- •Enrolled in an investigational study evaluating another device or drug.
结局指标
主要结局
The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation.
时间窗: 12-month post ablation
The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation.
The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure.
时间窗: Seven days post ablation procedure
The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure.
次要结局
- Number of Subjects Achieved Long-term Efficacy Success(3-year follow up)
- Percentage of Subjects Achieved Acute Success(Duration from post-procedure to hospital discharge, up to 2 days)
- Change in Left Ventricular Ejection Fraction at 6 Month From Baseline(6-month follow up)
- Percentage of Subjects Who Achieved Chronic Effectiveness(6-month follow up)