Mapping guided Stereotactic ablative Radiotherapy, hybrid treatment for uncontrollable ventricular tachycardia

Departments of Cardiology and Radiotherapy, Leiden University Medical Center0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年6月11日

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•-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 arrhythmic 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 24h)
•?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

•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

发起方

Departments of Cardiology and Radiotherapy, Leiden University Medical Center