Early Feasibility Study of Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia That Has Failed Conventional Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months
研究概览
简要总结
The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters.
The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.
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
- •Monomorphic ventricular tachycardia (VT) or incessant ventricular arrhythmia (defined as >20% of beats due to ventricular arrhythmia including unifocal premature ventricular contractions (PVCs ), couplets, nonsustained VT) that is causing a decline in left ventricular (LV) ejection fraction to less than 0.
- •Arrhythmia meets the following criteria:
- •Ventricular arrhythmia is recurrent and symptomatic
- •prior antiarrhythmic drug therapy has failed due to recurrent ventricular arrhythmia, toxicity, or intolerance
- •Age 18 or older
- •Left ventricular (LV) ejection fraction > 0.10 as estimated by echocardiography or contrast ventriculography within the previous 90 days
- •Failed prior VT or PVC ablation due to spontaneous recurrence of the arrhythmia or frequent PVCs.
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- •Signed Informed Consent
排除标准
- •Patients with idiopathic VT defined as VT that originates from a region without evidence of scar detected by MRI or voltage mapping in a patient without other evidence of heart disease that is not causing significant depression of ventricular function.
- •Definite protruding left ventricular thrombus on pre-ablation echocardiography when LV ablation is required.
- •Thrombotic myocardial infarction within the preceding two (2) months.
- •Other disease process that is likely to limit survival to less than 12 months.
- •Class IV heart failure, unless heart failure is due to frequent or incessant VT.
- •Contraindication to heparin.
- •Allergy to radiographic contrast dye.
- •Severe aortic stenosis
- •Severe mitral regurgitation with a flail mitral valve leaflet.
- •Significant congenital anomaly or medical problem that in the opinion of the principal investigator would preclude enrollment into the study.
- •Enrolled in another investigational study evaluating a drug or device.
- •Unstable angina that is not due to frequent or incessant VT.
- •Women who are pregnant.
- •Thrombocytopenia (platelet count < 50,000) or coagulopathy.
- •Acute non-cardiovascular illness or systemic infection.
- •Cardiogenic shock unless it is due to incessant VT
结局指标
主要结局
Number of Subjects Without Hospitalization for Ventricular Tachycardia (VT) During 6 Months
时间窗: 6 months
Freedom from hospitalization for recurrent Ventricular Tachycardia during the 6 months following ablation for VT.
Number of Subjects Ablated for Nonsustained Arrhythmias Who Had a Reduction to Less Than 5000 Arrhythmia Beats Daily
时间窗: 6 months
Number of subjects who had ablation for nonsustained arrhythmias with ventricular dysfunction who had a decrease in ambient ventricular arrhythmia to \< 5000 ventricular beats daily.
Number of Participants With No Serious Adverse Events
时间窗: 30 days
Absence of serious adverse events that are potentially device related and occur within 30 days of the ablation procedure
次要结局
- Number of Subjects With Acute Abolition of at Least One Clinical Inducible Ventricular Tachycardia or Targeted Nonsustained Arrhythmia(Baseline to end of the ablation procedure (approximately 5 hours))
研究者
William Stevenson
Professor, Cardiovascular Medicine
Vanderbilt University Medical Center