Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 73
- 主要终点
- Number of Subjects Who Experienced an ICD Shock Event.
研究概览
简要总结
To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.
详细描述
Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implant, which has study required programing capabilities and is appropriate for remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to enrollment are also eligible.
- •Patient who has a high risk of ICD shock as shown by at least one documented Monomorphic VT (MMVT)** by one or more of the following:
- •Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT during Non-Invasive Programmed Stimulation (NIPS) Study
- •18 to 75 years of age
- •Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.
- •Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is acceptable but polymorphic VT or ventricular fibrillation (VF) is not.
排除标准
- •Any history of stroke
- •S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days prior to enrollment
- •Patient is pregnant or nursing
- •Patient has New York Heart Association (NYHA) class IV heart failure
- •Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment (Patients with Incessant VT have continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥3) hours)
- •Patient has VT/VF thought to be from channelopathies
- •Limited life expectancy (less than one year) according to Investigator
- •Patient has current class IV angina
- •Recent coronary artery bypass graft (CABG < 60 days) or percutaneous coronary intervention (PCI < 30 days)
- •Patient is currently participating in another investigational drug or device study
- •Patient is unable or unwilling to cooperate with the study procedures
- •Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram (TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS > 1
- •Prosthetic mitral or aortic valve
- •Mitral or aortic valvular heart disease requiring immediate surgical intervention
- •Major contraindication to anticoagulation therapy or coagulation disorder
- •Left Ventricular Ejection Fraction < 15%
- •Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (> 3 months) outflow tract tachycardia
- •Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2 within the past 3 months
- •Patient has peripheral vascular disease that precludes LV access
- •Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD
- •Patient has reversible cause of VT
- •Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and Balloon pumps are acceptable)
- •There is a strong clinical reason to believe that, in the opinion of the investigator, the patient only has septal scar that is deep
研究组 & 干预措施
Drug with ICD/CRT-D
Implantable cardioverter defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) with routine drug therapy
Cardiac catheter ablation with ICD/CRT-D
Cardiac catheter ablation with ICD/CRT-D with routine drug therapy
干预措施: Cardiac catheter ablation with ICD/CRT-D (Device)
结局指标
主要结局
Number of Subjects Who Experienced an ICD Shock Event.
时间窗: 12 months
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Number of Subjects Who Experienced a Select Serious Adverse Event
时间窗: 30 days
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
次要结局
- Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit(12 months)