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
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