PDF(Pubmed)
Abstract：
Currently, the standard curative treatment for ventricular tachycardia (VT) and ventricular fibrillation (VF) is radiofrequency catheter ablation. However, when the VT circuit is deep in the myocardium, the catheter may not be delivered, and a new, minimally invasive treatment using different energies is desired.
This is a protocol paper for a feasibility study designed to provide stereotactic radiotherapy for refractory VT not cured by catheter ablation after at least one catheter ablation. The primary end point is to evaluate the short-term safety of this treatment and the secondary endpoint is to evaluate its efficacy as assessed by the reduction in VT episode. Cyberknife M6 radiosurgery system will be used for treatment, and the prescribed dose to the target will be 25Gy in one fraction. The study will be conducted on three patients.
Since catheter ablation is the only treatment option for VT that is covered by insurance in Japan, there is currently no other treatment for VT/VF that cannot be cured by catheter ablation. We hope that this feasibility study will provide hope for patients who are currently under the stress of ICD activation.
The study has been registered in the Japan Registry of Clinical Trials (jRCTs042230030).
This is a protocol paper for a feasibility study designed to provide stereotactic radiotherapy for refractory VT not cured by catheter ablation after at least one catheter ablation. The primary end point is to evaluate the short-term safety of this treatment and the secondary endpoint is to evaluate its efficacy as assessed by the reduction in VT episode. Cyberknife M6 radiosurgery system will be used for treatment, and the prescribed dose to the target will be 25Gy in one fraction. The study will be conducted on three patients.
Since catheter ablation is the only treatment option for VT that is covered by insurance in Japan, there is currently no other treatment for VT/VF that cannot be cured by catheter ablation. We hope that this feasibility study will provide hope for patients who are currently under the stress of ICD activation.
The study has been registered in the Japan Registry of Clinical Trials (jRCTs042230030).
摘要：
■目前，室性心动过速(VT)和室颤(VF)的标准治疗方法是射频导管消融.然而,当VT电路在心肌深处时，导管可能无法输送，一个新的,需要使用不同能量的微创治疗。
■这是一项可行性研究的协议文件，旨在为至少一次导管消融后未通过导管消融治愈的难治性室性心动过速提供立体定向放射治疗。主要终点是评估该治疗的短期安全性，次要终点是通过减少VT发作来评估其疗效。射波刀M6放射外科系统将用于治疗，和规定的剂量的目标将是25Gy在一个部分。该研究将对三名患者进行。
■由于导管消融是在日本保险范围内的室性心动过速的唯一治疗选择，目前尚无其他无法通过导管消融治愈的VT/VF治疗方法.我们希望这项可行性研究将为目前处于ICD激活压力下的患者提供希望。
■该研究已在日本临床试验注册中心（jRCTs042230030）注册。
■这是一项可行性研究的协议文件，旨在为至少一次导管消融后未通过导管消融治愈的难治性室性心动过速提供立体定向放射治疗。主要终点是评估该治疗的短期安全性，次要终点是通过减少VT发作来评估其疗效。射波刀M6放射外科系统将用于治疗，和规定的剂量的目标将是25Gy在一个部分。该研究将对三名患者进行。
■由于导管消融是在日本保险范围内的室性心动过速的唯一治疗选择，目前尚无其他无法通过导管消融治愈的VT/VF治疗方法.我们希望这项可行性研究将为目前处于ICD激活压力下的患者提供希望。
■该研究已在日本临床试验注册中心（jRCTs042230030）注册。
