Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Time to composite event
研究概览
简要总结
This study compares two arms - the current standard of care catheter ablation for Ventricular Tachycardia compared to stereotactic radiotherapy to non-invasively ablate ventricular tachycardia using a novel non-invasive ECG based body surface mapping technology. This allows investigators to identify ventricular tachycardia circuits to target for subsequent radio ablation. To summarize, the current standard of care invasive catheter ablation to the non-invasive radio ablation.
详细描述
Currently patients suffering Ventricular Tachycardia (VT) are offered drugs, such as Amiodarone, Implantable cardioverter defibrillatorf (ICD) implant and catheter ablation. Although effective drugs have side effects, ICD shocks are painful and catheter ablation is arduous for patients at high risk of complications. Catheter ablation is currently the gold standard treatment for recurrent VT despite anti-arrhythmic drugs (AADs).
Catheter ablation (CA) was initially developed in the 1980s following the successful treatment of VT by surgical resection of myocardial scarring in structural heart disease. After thorough clinical evaluation and medical stabilization, imaging is performed to identify culprit areas for ablation and to stratify risk of intervention. Pre procedural imaging in patients with ICDs in situ involves Echocardiography, Computerized Tomography (CT) scanning and Positron Emission Tomography (PET) imaging in order to assess cardiac function, ischemia, inflammation and scarring. If necessary mechanical circulatory support, Left Ventricular Assist Devices (LVAD) and/ or Extra Corporeal Membrane Oxygenation (ECMO) can be used to sustain cardiac output during VT induction and mapping.
Radiofrequency (RF) energy delivered via catheter to the arrhythmogenic target results in local resistive heating and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. Conventional approaches involve advancing multiple catheters via Femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, "scar", identified during endocardial mapping. CA procedures for VT are often long, averaging 5 hours duration reported in clinical trials, with prolonged procedures being associated with adverse outcomes and 30 day complication rates, including death, of 7- 13%.
Vulnerable patients requiring circulatory support or at high risk of recurrence and death following catheter ablation can be identified pre-operatively. Of all patients undergoing CA for VT, more than a third are "high risk" with a one year risk of death of >20%. Patients older than 65 with prior catheter ablation and recurrent VT with impaired left ventricular ejection fraction ≤35% have 90 day VT recurrence rates of 30% and mortality of 20%.
Patients with comorbidities such as Diabetes or COPD and those presenting in VT storm are also at high risk of hemodynamic compromise and death following Catheter Ablation. Without prophylactic LVAD placement, patients at high risk of haemodynamic instability (PAINESD score ≥ 15) suffer 30% death at thirty days with 41% VT recurrence post CA. It is these "high risk" patients that we believe will benefit from a non-invasive RA approach.
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
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥55 years of age
- •Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND
- •Recurrent VT events despite previous CA OR
- •VT events requiring intervention and PAINESD score ≥ 15
排除标准
- •Patients with NYHA Class IV heart failure &/ or with LVAD in situ
- •Patients not expected to live for more than one year for any reason
- •Patients who have previously received thoracic radiotherapy
- •Patients who are enrolled in another randomized clinical trial
- •Patients who are unable or unwilling to provide informed consent
- •Patients aged ≤54 years of age
- •Pregnancy (all women of child bearing age and potential will have a negative β-HCG test before enrollment)
- •Breastfeeding
- •Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception (IUD, sterilization, birth control implant or birth control pill) throughout the study.
结局指标
主要结局
Time to composite event
时间窗: 14 days
Composite event including death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days, treated sustained ventricular tachycardia below the detection rate of the ICD after 14 days
次要结局
- Number of Anti-tachycardia pacing (ATP)(3 years)
- Appropriate shocks(at any time or after 14 days)
- VT storm at any time or after 14 days(at any time or after 14 days)
- Number of ventricular arrhythmia events(3 years)
- Hospital admission for cardiac causes(3 years)
- Heart Failure decompensation /death(3 years)
- Procedural complications and/ or antiarrhythmic drug adverse effects(3 years)
- Appropriate ICD ATP at any time or after 14 days(at any time or after 14 days)
- Sustained VT not treated by ICD at any time or after 14 days(at any time or after 14 days)
- Inappropriate ICD shocks at any time or after 14 days(at any time or after 14 days)
- Any ICD shock at any time or after 14 days(at any time or after 14 days)
- Any ventricular arrhythmia event at any time or after 14 days(at any time or after 14 days)
- Number of ICD shocks (all cause)(3 years)
- Number of ICD appropriate therapy(3 years)
- Number of VT storm events(3 years)
- Patient Quality of life - SF36(3 years)
- Cost-effectiveness(3 years)
- Escalation and De-escalation of antiarrhythmic medication(3 years)