Clinical feasibility study of Noninvasive Cardiac Radio-ablation for Treatment of Ventricular tachycardia
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
Background: Noninvasive cardiac radioablation is reported to be effective and safe for the treatment of ventricular tachycardia (VT). Objective: This study aimed to analyze the acute and long-term effects of VT radioablation. Methods: Patients with intractable VT or premature ventricular contraction (PVC)-induced cardiomyopathy were included in this study and treated using a single-fraction 25-Gy dose of cardiac radioablation. To quantitatively analyze the acute response after treatment, continuous electrocardiography monitoring was performed from 24 hours before to 48 hours after irradiation and at the 1-month follow-up. Long-term clinical safety and efficacy were assessed 1-year follow-up. Results: From 2019 to 2020, 6 patients were treated with radioablation for ischemic VT (n = 3), nonischemic VT (n = 2), or PVC-induced cardiomyopathy (n = 1). In the short-term assessment, the total burden of ventricular beats decreased by 49% within 24 hours after radioablation and further decreased by 70% at 1 month. The VT component decreased earlier and more dramatically than the PVC component (decreased by 91% and 57% at 1 month, respectively). In the long-term assessment, 5 patients showed complete (n = 3) or partial (n = 2) remission of ventricular arrhythmias. One patient showed recurrence at 10 months, which was successfully suppressed with medical treatment. The posttreatment PVC coupling interval was prolonged (+38 ms at 1 month). Ischemic VT burden decreased more markedly than nonischemic VT burden after radioablation. Conclusion: In this small case series of 6 patients, without a comparison group, cardiac radioablation appeared to decrease the intractable VT burden. A therapeutic effect was apparent within 1-2 days after treatment but was variable by etiology of cardiomyopathy.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Documented ventricular tachycardia
- •[1] Symptomatic ventricular tachycardia over 2 times on 12-leads ECG, Rhythm strip or implantable devices, within recent 6 months
- •[2] ICD therapy (shock or ATP) within 6 months
- •[3] In the case of PVC induced heart failure (LVEF <50%): PVC burden is over 15% on holter monitoring
- •2) Failed standard therapy for ventricular tachycardia
- •[1] Patients who are unable to adapt to antiarrhythmic medications or whose ventricular tachycardia is uncontrolled even after 2 months of adequate treatment
- •--AND--
- •[2] Previous failed catheter ablation for ventricular tachycardia or were not suitable for catheter ablation (left ventricular thrombosis, severe lung disease, vascular abnormality, heart malformation, etc.)
- •3) Those whose life expectancy is expected to decrease due to ventricular tachycardia (required by the expert cardiologist)
- •4) Left ventricular ejection function = 15%
- •5) Functional class: NYHA class = II
- •6) 19 years old or older
排除标准
- •1) Those who do not agree to study registration
- •2) Those whose radiation therapy is not medically appropriate
- •-When a suitable posture for radiation therapy is not possible
- •-Others who are judged unsuitable by the judgment of radiation oncologist.
- •3) Those who have an extracorporeal circulatory system (ECMO) or left ventricular assist device or who require high-dose inopropics due to a cause other than ventricular tachycardia, (if the dose of Dopamine or Dobutamine is higher than 10 mcg / kg / min)
- •4) Life expectancy is less than 12 months, even if there is no ventricular tachycardia due to other diseases.
- •5) Pregnant or breast feeding