PDF(Pubmed)
Abstract：
UNASSIGNED: Monomorphic ventricular tachycardia (VT) is a life-threatening condition often observed in patients with structural heart disease. Ventricular tachycardia ablation through radiation therapy (VT-ART) for sustained monomorphic ventricular tachycardia seems promising, effective, and safe. VT-ART delivers focused, high-dose radiation, usually in a single fraction of 25 Gy, allowing ablation of VT by inducing myocardial scars. The procedure is fully non-invasive; therefore, it can be easily performed in patients with contraindications to invasive ablation procedures. Definitive data are lacking, and no direct comparison with standard procedures is available.
UNASSIGNED: The aim of this multicenter observational study is to evaluate the efficacy and safety of VT-ART, comparing the clinical outcome of patients undergone to VT-ART to patients not having received such a procedure. The two groups will not be collected by direct, prospective accrual to avoid randomization among the innovative and traditional arm: A retrospective selection through matched pair analysis will collect patients presenting features similar to the ones undergone VT-ART within the consortium (in each center independently). Our trial will enroll patients with optimized medical therapy in whom endocardial and/or epicardial radiofrequency ablation (RFA), the gold standard for VT ablation, is either unfeasible or fails to control VT recurrence. Our primary outcome is investigating the difference in overall cardiovascular survival among the group undergoing VT-ART and the one not exposed to the innovative procedure. The secondary outcome is evaluating the difference in ventricular event-free survival after the last procedure (i.e., last RFA vs. VT-ART) between the two groups. An additional secondary aim is to evaluate the reduction in the number of VT episodes comparing the 3 months before the procedure to the ones recorded at 6 months (from the 4th to 6th month) following VT-ART and RFA, respectively. Other secondary objectives include identifying the benefits of VT-ART on cardiac function, as evaluated through an electrocardiogram, echocardiographic, biochemical variables, and on patient quality of life. We calculated the sample size (in a 2:1 ratio) upon enrolling 149 patients: 100 in the non-exposed control group and 49 in the VT-ART group. Progressively, on a multicentric basis supervised by the promoting center in the VT-ART consortium, for each VT-ART patient enrollment, a matched pair patient profile according to the predefined features will be shared with the consortium to enroll a patient that has not undergone VT-ART.
UNASSIGNED: Our trial will provide insight into the efficacy and safety of VT-ART through a matched pair analysis, via an observational, multicentric study of two groups of patients with or without VT-ART in the multicentric consortium (with subgroup stratification into dynamic cohorts).
UNASSIGNED: The aim of this multicenter observational study is to evaluate the efficacy and safety of VT-ART, comparing the clinical outcome of patients undergone to VT-ART to patients not having received such a procedure. The two groups will not be collected by direct, prospective accrual to avoid randomization among the innovative and traditional arm: A retrospective selection through matched pair analysis will collect patients presenting features similar to the ones undergone VT-ART within the consortium (in each center independently). Our trial will enroll patients with optimized medical therapy in whom endocardial and/or epicardial radiofrequency ablation (RFA), the gold standard for VT ablation, is either unfeasible or fails to control VT recurrence. Our primary outcome is investigating the difference in overall cardiovascular survival among the group undergoing VT-ART and the one not exposed to the innovative procedure. The secondary outcome is evaluating the difference in ventricular event-free survival after the last procedure (i.e., last RFA vs. VT-ART) between the two groups. An additional secondary aim is to evaluate the reduction in the number of VT episodes comparing the 3 months before the procedure to the ones recorded at 6 months (from the 4th to 6th month) following VT-ART and RFA, respectively. Other secondary objectives include identifying the benefits of VT-ART on cardiac function, as evaluated through an electrocardiogram, echocardiographic, biochemical variables, and on patient quality of life. We calculated the sample size (in a 2:1 ratio) upon enrolling 149 patients: 100 in the non-exposed control group and 49 in the VT-ART group. Progressively, on a multicentric basis supervised by the promoting center in the VT-ART consortium, for each VT-ART patient enrollment, a matched pair patient profile according to the predefined features will be shared with the consortium to enroll a patient that has not undergone VT-ART.
UNASSIGNED: Our trial will provide insight into the efficacy and safety of VT-ART through a matched pair analysis, via an observational, multicentric study of two groups of patients with or without VT-ART in the multicentric consortium (with subgroup stratification into dynamic cohorts).
摘要：
UNASSIGNED：单形性室性心动过速（VT）是一种威胁生命的疾病，通常在结构性心脏病患者中观察到。通过放射治疗（VT-ART）进行室性心动过速消融治疗持续性单形性室性心动过速似乎很有希望。有效,和安全。VT-ART提供聚焦,高剂量辐射,通常是25Gy的一小部分，通过诱导心肌疤痕来进行室性心动过速消融。该程序是完全非侵入性的；因此，对于有侵入性消融手术禁忌症的患者，可以很容易地进行。缺乏明确的数据，和标准程序没有直接比较是可用的。
UNASSIGNED：这项多中心观察性研究的目的是评估VT-ART的疗效和安全性，比较接受VT-ART的患者与未接受此类手术的患者的临床结局.两组不会直接收集,前瞻性应计以避免在创新和传统领域中进行随机化：通过配对分析的回顾性选择将收集具有与联盟内（在每个中心独立）接受VT-ART的患者相似的特征的患者。我们的试验将纳入优化药物治疗的患者，其中心内膜和/或心外膜射频消融（RFA），室性心动过速消融的黄金标准，要么不可行，要么无法控制VT复发。我们的主要结果是调查接受VT-ART的组和未接受创新程序的组之间总体心血管生存率的差异。次要结果是评估最后一次手术后无心室事件生存率的差异(即，上一次RFAvs.VT-ART）在两组之间。另一个次要目的是评估室性心动过速发作次数的减少，将手术前3个月与室性心动过速ART和RFA后6个月（第4个月至第6个月）记录的室性心动过速发作次数进行比较，分别。其他次要目标包括确定VT-ART对心脏功能的益处，通过心电图评估，超声心动图,生化变量，以及患者的生活质量。我们计算了149名患者的样本量（以2：1的比例）：非暴露对照组100名，VT-ART组49名。逐步,在VT-ART联盟促进中心的多中心监督下，对于每个VT-ART患者登记，根据预定义特征的配对患者档案将与联盟共享,以纳入未接受VT-ART的患者.
UNASSIGNED：我们的试验将通过配对分析深入了解VT-ART的疗效和安全性，通过观测，在多中心联盟中对两组有或没有VT-ART的患者进行多中心研究（将亚组分层为动态队列）。
UNASSIGNED：这项多中心观察性研究的目的是评估VT-ART的疗效和安全性，比较接受VT-ART的患者与未接受此类手术的患者的临床结局.两组不会直接收集,前瞻性应计以避免在创新和传统领域中进行随机化：通过配对分析的回顾性选择将收集具有与联盟内（在每个中心独立）接受VT-ART的患者相似的特征的患者。我们的试验将纳入优化药物治疗的患者，其中心内膜和/或心外膜射频消融（RFA），室性心动过速消融的黄金标准，要么不可行，要么无法控制VT复发。我们的主要结果是调查接受VT-ART的组和未接受创新程序的组之间总体心血管生存率的差异。次要结果是评估最后一次手术后无心室事件生存率的差异(即，上一次RFAvs.VT-ART）在两组之间。另一个次要目的是评估室性心动过速发作次数的减少，将手术前3个月与室性心动过速ART和RFA后6个月（第4个月至第6个月）记录的室性心动过速发作次数进行比较，分别。其他次要目标包括确定VT-ART对心脏功能的益处，通过心电图评估，超声心动图,生化变量，以及患者的生活质量。我们计算了149名患者的样本量（以2：1的比例）：非暴露对照组100名，VT-ART组49名。逐步,在VT-ART联盟促进中心的多中心监督下，对于每个VT-ART患者登记，根据预定义特征的配对患者档案将与联盟共享,以纳入未接受VT-ART的患者.
UNASSIGNED：我们的试验将通过配对分析深入了解VT-ART的疗效和安全性，通过观测，在多中心联盟中对两组有或没有VT-ART的患者进行多中心研究（将亚组分层为动态队列）。
