NL-OMON52679招募中不适用
Mapping guided Stereotactic ablative Radiotherapy, Hybrid treatment for uncontrollable ventricular tachycardia - Mapping guided Stereotactic ablative Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
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
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •- Age >=18
- •- Implanted ICD
- •- Structural heart disease with myocardial scar
- •- World Health Organization (WHO) / Eastern Cooperative Oncology Group (ECOG)
- •performance status grade 0-3 in the past 3 months, or grade 4 if related to the
- •ar-rhythmic presentation (from fully active to capable of limited self-care,
- •see below for full explanation)
- •- Presenting with at least one of the following
- •* Within the past 3 months: electrical storm (defined as >=3 ICD shocks within
- •* Within the past 3 months: 3 or more episodes of highly symptomatic sustained
- •VT (either requiring ICD shocks, or leading to (pre)syncope)
- •* Recurrent VT (high VT burden) leading to progressive heart failure
- •* Symptomatic, incessant VT not detected by the device or reinitiating after
- •ICD therapy
- •* Progressive heart failure and indication for LVAD, in whom recurrent VT
- •preclude LVAD implantation
- •- Despite all of the following
- •* Optimal medical treatment according to current guidelines
- •* Failure of recommended antiarrhythmic drugs including failure of amiodarone
- •* Failure of catheter ablation using the current state of the art catheter
- •ablation techniques to modify the VT substrate
- •- Able and willing to undergo all necessary evaluations, treatment and
- •follow-up for the study and of follow-up thereafter
- •- Informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Pregnancy
- •- Interstitial pulmonary disease
- •- Irreversible renal insufficiency with a glomerular filtration rate <30ml/min
- •(not related to the high VT burden)
- •- Life expectancy <12 months in the absence of VT
- •- Refusal or inability to provide informed consent or to undergo all
- •necessary evaluations, treatment and follow-up for the study
研究者
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