Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VT burden
研究概览
简要总结
The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:
- What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months
- What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).
详细描述
Hypothesis
We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia (VT) that stereotactic body radiation therapy (SBRT) will be superior in reducing VT burden compared to standard care comprising of catheter ablation (CA) and routine medical care with acceptable safety and adverse events.
Aims
This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in:
- An improvement in a primary outcome of proportion of patients with a ≥75% reduction in VT burden in the 6 months following intervention compared to the 6 months intervention
- Comparable safety profile (serious adverse events [SAE] and adverse events of special interest [AESI] at 6 months;
- reduction in secondary endpoints at 6, 12, 24 and 36 months of: any VT recurrence, absolute % reduction in VT burden compared to 6 months pre-treatment, number of anti-arrhythmic drugs (AADs) compared to pre-treatment, cardiovascular hospitalisation, all-cause mortality, cardiac transplantation, combined endpoint of cardiovascular hospitalisation/transplant/mortality, SAE and AESI from treatment, ventricular function abd change of quality of life (QOL) metrics (at 12 months).
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
- Single (Outcomes Assessor)
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
- •Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of
- •segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI
- •myocardial hypertrophy
- •myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)
- •Recurrent monomorphic VT which can include
- •at least one episode of VT treated by ICD and/or
- •sustained VT (lasting >30s) and/or
- •inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)
- •PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA.
排除标准
- •Age < 18 years
- •Life expectancy < 3 months
- •Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
- •Unwilling or unable to provide consent
- •Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
- •Contraindications to radiotherapy as deemed by referring physician and/or radiation oncologist
- •Pregnancy or breast feeding
研究组 & 干预措施
Catheter ablation
CA within 6 weeks of randomisation (constituting standard of care for patients with VT and structural heart disease)
干预措施: CA (Procedure)
Stereotactic body radiation therapy
SBRT within 6 weeks of randomisation guided by previous electrophysiology studies, electrocardiograms and cardiac imaging.
干预措施: SBRT (Radiation)
结局指标
主要结局
VT burden
时间窗: 6 months
Change in proportion of patients with a ≥75% reduction in VT burden at 6 months (number of VT episodes in 6 months post treatment compared to the number of VT episodes in the 6 months prior to randomisation excluding a 6-week blanking period after treatment initiation)
次要结局
- ICD shocks(6, 12, 24 and 36 months)
- VT storm(6, 12, 24 and 36 months)
- Recurrent sustained VT(6, 12, 24 and 36 months)
- All cause mortality(6,12, 24 and 36 months)
- Cardiovascular Mortality(6,12, 24 and 36 months)
- Ventricular function(6,12, 24 and 36 months)
- Quality of Life as per Short Form - 36 (SF-36) Score(6,12, 24 and 36 months)
- Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score(6,12, 24 and 36 months)
- Absolute VT burden(6, 12, 24 and 36 months)
- Hospitalization(6, 12, 24 and 36 months)
- Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation(6,12, 24 and 36 months)
- Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)(At all time points up to 36 months)
- Number of AADs(6,12, 24 and 36 months)
研究者
Saurabh Kumar
Associate Professor
Western Sydney Local Health District