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临床试验/JPRN-jRCTs032190041
JPRN-jRCTs032190041招募中2 期

Minimally Invasive Arrhythmia Treatment with External Radiation Therapy for Intractable Ventricular Tachycardia

Yoshioka Koichiro0 个研究点目标入组 8 人开始时间: 2019年6月19日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
8

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

年龄范围
>= 18age old 至 ot applicable(—)
性别
All

入选标准

  • Eligible patients had more than 3 episodes of sustained monomorphic VT or cardiomyopathy* (left ventricular ejection fraction less than 50%) related to monomorphic premature ventricular contractions (PVCs beyond 20%) and required failure of more than 1 antiarrhythmic medication and more than 1 catheter ablation (or had a contraindication to catheter ablation such as anatomical difficulty or epicardial origin, or patient's rejection**). Patients could not have received past radiotherapy to the anticipated treatment field.
  • *Cardiomyopathy can be ischemic or non-ischemic (idiopathic, contractile pericarditis, valvular disease, etc.)
  • **Even if two independent cardiologists give enough explanation, it is assumed that the patient's informed consent was not obtained.

排除标准

  • Patients were deemed ineligible if they had heart failure dependent on inotropes or a left-ventricular assist device or were deemed unlikely to live 12 months in the absence of VT. Patients were also ineligible if they had polymorphic VT or ventricular fibrillation, beyond 3 distinct clinical VT morphologies, or beyond 5 induced VT morphologies during noninvasive-programmed stimulation testing by using ICD.
  • Even if the above selection criteria and exclusion criteria are met, patients who fall under any of the following conditions are excluded
  • 1. Maintenance hemodialysis or peritoneal dialysis is performed.
  • 2. Organic heart disease requiring surgical treatment.
  • 3. Hospitalization is required for acute coronary syndrome or acute heart failure.
  • 4. High risk of radiation pneumonitis, eg evidence of idiopathic pulmonary fibrosis on chest CT.
  • 5. The research investigator or associate physician judges that participation in this study is inappropriate. For example, it may be considered difficult to carry out necessary tests and follow-up due to other diseases or reasons.

研究者

发起方
Yoshioka Koichiro

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