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临床试验/NCT02962076
NCT02962076终止早期 1 期

Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia

Khaled Awad, MD1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年9月21日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
终止
入组人数
11
试验地点
1
主要终点
Correlation Between PET Data and Electroanatomic Data

研究概览

简要总结

Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Clinical indication for ventricular tachycardia (VT) ablation (at least one clinical episode of sustained VT) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one
  • Ischemic or nonischemic cardiomyopathy
  • Sustained monomorphic VT

排除标准

  • Right ventricular VT
  • Polymorphic VT or ventricular fibrillation (VF) being the sole detected clinical arrhythmia
  • Patient is unable to sign informed consent
  • Recent myocardial infarction less than 30 days
  • Recent ablation for ventricular tachycardia less than 30 days
  • Patient is unwilling or unable to cooperate with the study
  • Prosthetic mitral or aortic valve
  • General contraindications to VT ablation, e.g., major contraindication to anticoagulation therapy, known presence of left ventricular thrombus, reversible causes of VT or VF
  • General contraindications to PET imaging, e.g., pregnancy or lactation
  • General contraindication to magnetic resonance imaging or to the administration of gadolinium.
  • Contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access

研究组 & 干预措施

Single Arm - PET/CT Imaging With [C-11] MHED

Experimental

Single Arm - positron emission tomography/computed tomography imaging with [C-11] meta-Hydroxyephedrine tracer

干预措施: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED) (Drug)

结局指标

主要结局

Correlation Between PET Data and Electroanatomic Data

时间窗: 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Khaled Awad, MD

MD

Mercy Research

研究点 (1)

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