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临床试验/ACTRN12623000062628
ACTRN12623000062628招募中未知

Assessment of the acute safety of cardiac stereotactic ablative radiotherapy for the treatment of ventricular tachycardia

Chris O'Brien Lifehouse0 个研究点目标入组 15 人开始时间: 2023年1月18日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1. The participant must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation
  • b. Monomorphic PVCs documented on a 12-lead ECG.
  • 2. The patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
  • 3. The participant must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery).
  • 4. Participant must have either at least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrolment
  • b. >20% PVC burden with a cardiomyopathy (LVEF<50%)
  • 5. Participant must be deemed medically fit for stereotactic ablative body radiotherapy by the treating cardiologist and radiation oncologist.
  • 6. Participant must be over the age of 18 years old.
  • 7. Participant must have willingness to provide informed consent and a willingness to participate and comply with the study requirements.

排除标准

  • 1.Prior radiotherapy within the treatment field
  • 2.Heart failure dependent on inotropes or left-ventricular assist device
  • 3.Ventricular fibrillation, >3 distinct clinical VT morphologies or > 5 VT induced VT morphologies during previous electrophysiology studies.
  • 4.Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician
  • 5.Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.

研究者

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