ISRCTN49861434进行中(未招募)Unknown
Magnetic resonance guided radiotherapy to the stellate ganglia for ventricular arrhythmia
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Male or Female, aged at least 18 years old.
- •2.Known diagnosis of structural heart disease defined as any patient with impaired left ventricular ejection fraction (less than 55%) due to any cause including; ischaemic cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy or Arrhythmogenic cardiomyopathy.
- •3.CMR compatible ICD device implanted a minimum of 6 months ago, under follow-up at Oxford University Hospitals NHS Foundation Trust.
- •4.Experienced more than one appropriate ICD therapy (shocks or anti-tachycardia pacing) for ventricular arrhythmia in the last 6 months
- •5.Established on optimal guideline based medical therapy for heart failure
排除标准
- •General Exclusion Criteria:
- •1.Device radiation dose or nearby organs at risk exceeding the limit for low-risk radiotherapy as defined by the UK Consensus and AAPM 2019 guidelines
- •2.Female patients who are pregnant, lactating or planning pregnancy during the study period
- •3.Patients who are terminally ill, inappropriate for intervention, or unable to consent
- •4.Any impediment to communication which, in the opinion of the investigator, might prevent the investigator communicating effectively with the patient during the study which could cause a safety or reliability concern.
- •5.Any other condition which, in the opinion of the investigator, might affect the safety of the participant or reduce the reliability of the study results
- •6.Involvement in any other research project where the procedures would affect the outcomes of this study.
- •Additional Exclusion Criteria for Participants Undergoing MRI Studies:
- •7.Metal clips or metallic foreign body
- •8.Prior injury to the eye involving fragments of metal
- •9.Prior shrapnel injuries
- •10.Any other metallic or electronic implants affected by the magnetic field
- •11.History of severe claustrophobia
- •12.Severe liver damage, TB, pulmonary disease, anaemia, blood coagulation disorders
研究者
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