Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The burden of ventricular arrhythmias, defined as the total number of sustained ventricular tachycardia (sVT) events recorded during the 6-month observation period.
研究概览
简要总结
The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).
详细描述
Study Objectives:
To evaluate the safety and efficacy of Stereotactic Arrhythmia Radioablation (STAR) as a second-line therapy for sustained Ventricular Tachycardia (sVT) in optimally treated patients following endocardial Catheter Ablation (CA).
Study Design:
This study is a single-center randomized, noninferiority, head-to-head control trial comparing the efficacy and safety of two ablation methods for recurrent sVT after failing CA.
Patient Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the distinct nature of the interventional procedures, blinding of the study is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of enrollment.
- •Presence of structural heart disease (SHD) of either ischemic or non-ischemic etiology.
- •Implanted ICD or CRT-D device for primary or secondary prevention of sudden cardiac death (SCD).
- •History of at least one endocardial CA procedure targeting a substrate of monomorphic sVT.
- •Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.
- •Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management.
- •Provision of written informed consent prior to study participation.
排除标准
- •Reversible cause of sVT recurrence, particularly acute coronary syndrome (ACS), acute myocarditis, or lead-related infective endocarditis (LDIE).
- •Myocardial infarction (MI) or cardiac surgery within the last 40 days.
- •Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies.
- •Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved.
- •Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.
- •Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.
- •A mobile thrombus within the left ventricle (LV).
- •Presence of a left ventricular assist device (LVAD).
- •Presence of comorbidities or known risk factors for CA complications that, in the judgment of the electrophysiologist, constitute a contraindication to the procedure for safety reasons.
- •Active, uncontrolled malignancy and/or chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure.
- •Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months.
- •Presence of comorbidities or known risk factors for radiotherapy complications that, in the judgment of the radiation oncologist, constitute a contraindication to STAR for safety reasons.
- •Pregnancy or breastfeeding.
- •Systemic disease that limits the probability of survival to less than 1 year
- •Other comorbidities, addictions, or social indications that, in the investigator's opinion, would preclude practical cooperation or otherwise disqualify the patient from participation in the clinical study.
- •Refusal to participate or lack of written informed consent for study participation.
结局指标
主要结局
The burden of ventricular arrhythmias, defined as the total number of sustained ventricular tachycardia (sVT) events recorded during the 6-month observation period.
时间窗: 6 months
Each documented sustained ventricular tachycardia (sVT) event, captured via electrocardiogram (ECG) or intracardiac electrogram (EGM) from the CIED memory, will be subject to physician adjudication. Automatic classification of arrhythmia type, number of sVT episodes, and number of therapies performed by the CIED will be accepted only in cases where EGM recordings are unavailable, e.g., due to device memory overflow resulting from a high volume of episodes. sVT criteria: 1. Meets detection criteria in the active VT or VF zone programmed in the ICD/CRT-D and triggers an appropriate therapy; or 2. Meets detection criteria in the VT monitoring zone programmed in the ICD/CRT-D and lasts ≥ 30 seconds; or 3. Is misclassified by the ICD/CRT-D as a supraventricular tachycardia but is reclassified as sVT after physician review of the EGM; or 4. Is recorded on surface ECG with a duration of ≥ 30 seconds.
Absence of treatment-related serious adverse events (SAEs) during the 18-month follow-up period
时间窗: 18 months
All adverse events (AEs) assessed by the investigator as having a probable causal relationship with either the experimental therapy or standard therapy will be classified as adverse events and recorded in the study protocol. Serious Adverse Events (SAEs) Each adverse medical event meeting any of the following criteria will be classified as a Serious Adverse Event (SAE): * Results in the death of the patient. * Is life-threatening to the patient. * Results in permanent or significant disability or requires intervention to prevent permanent damage to tissues or organs. * Requires re-hospitalization or leads to an extension of the hospitalization related to the procedure by more than 24 hours.
次要结局
- Reduction in ventricular arrhythmia burden, measured as the percentage decrease in the mean monthly number of sustained ventricular tachycardia events during the 6-month follow-up after therapy initiation, compared to corresponding period pre-treatment(6 months)
- Occurrence of sVT during the 18-month follow-up period(18 months)
- Time to first occurrence of sVT during the 18-month follow-up period.(18 months)
- Number of appropriate ICD/CRT-D therapies delivered during the 18-month follow-up period.(18 months)
- Number of hospitalizations due to arrhythmic causes during the 18-month follow-up period.(18 months)
- All-cause mortality during the 18-month follow-up period.(18 months)
- Improvement in quality of life assessed using the Polish version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire during the 18-month follow-up period.(18 months)