NCT04770051撤回1 期
Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Freedom from implantable cardioverter-defibrillator shock
研究概览
简要总结
The purpose of this research study is to examine the effect of percutaneous inferior cervical sympathetic block on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Appropriate ICD shock for ventricular tachycardia (VT) after at least one catheter ablation of VT procedure, OR appropriate ICD shock for VT but not a candidate for catheter ablation of VT (i.e. patients with presence polymorphic VT or ventricular fibrillation, LV thrombus, VT arising from an inaccessible myocardial location).
- •Presence of structural heart disease as defined as EF ≤ 50%, presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
- •Patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug.
- •Age greater than 18 years old.
- •Able and willing to comply with all pre- and follow-up testing and requirements.
- •Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study.
排除标准
- •Active ongoing cardiac ischemia as assessed by: EKG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to ICD shocks is not an exclusion criterion).
- •Any medical or non-medical condition likely to prevent completion of trial.
- •Contraindication to cardiac sympathetic denervation (i.e. single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure.
- •Left ventricular assist device or status post orthotopic heart transplantation
- •Severe thrombocytopenia (platelets < 50,000) or coagulopathy (INR > 2.0) that is not due to medications or a reversible cause.
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- •Unable or unwilling to comply with protocol requirements.
- •NYHA class IV heart failure symptoms.
- •Known channelopathy such as long QT syndrome and catecholaminergic polymorphic VT.
- •Presentation with slow VT (VT rate < 150 bpm).
结局指标
主要结局
Freedom from implantable cardioverter-defibrillator shock
时间窗: 3 months
Zero number of required cardioverter-defibrillator shocks in the patient's medical records
次要结局
未报告次要终点
研究者
Adnan Qureshi
Professor of Neurology
University of Missouri-Columbia
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