Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Recurrence of Ventricular Tachycardia
研究概览
简要总结
This study aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease
详细描述
This is a multicenter, randomized prospective cohort study to compare the impact of catheter ablation with antiarrhythmic drug therapy for treating patients with sustained ventricular tachycardia (VT) and coronary artery disease. Patients that meet all inclusion criteria and no exclusion criteria will be recruited to the study cohort. After baseline measurements are taken, patients will be randomized in a 2:1 fashion to either undergo radiofrequency catheter ablation or receive antiarrhythmic drug therapy (amiodarone or sotalol). The in-clinic appointments include: enrollment, baseline, intervention, and follow-up every three months for one year post-ablation. At each follow-up visit, electrogram (ECG) and Holter monitoring tests will be performed to measure any episodes of ventricular tachyarrhythmia. Furthermore, interrogation of the patient's implantable cardioverter defibrillator (ICD) will be performed at all follow-up visits to detect any episodes of ventricular tachyarrhythmia that required antitachycardia pacing (ATP) or shocks.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained monomorphic VT (>30 seconds, or requiring appropriate ICD therapy in patients with ICDs)
- •Documented ischemic heart disease with no further options for revascularization
- •Ability and willingness to give written informed consent to participate in the trial
排除标准
- •VT in the setting of metabolic abnormalities or acute ischemia if coronary lesions suitable for revascularization are identified.
- •Acute ischemia with eligibility for revascularization
- •Significant peripheral arterial disease preventing transvascular access to the left ventricle.
- •Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy, Brugada syndrome, Long QT syndromes, dilated cardiomyopathy
- •Prior long term therapy with a Class III or Class IC antiarrhythmic agent (longer than 2 weeks)
- •Patient is or may be potentially pregnant
- •Patient has a mechanical heart valve
- •Myocardial infarction within the past 90 days
- •Stroke within the past 90 days
- •New York Heart Association (NYHA) functional class IV
- •Hemorrhagic manifestations, bleeding diathesis, or impairment of hemostasis
- •Lesions at risk of clinically significant bleeding (e.g., extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding)
- •Prior VT ablation procedure
- •Contraindication or allergy to contrast media, routine procedural medications or catheter materials
- •Contraindications to an interventional procedure
- •Life expectancy is less than 6 months
- •Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
- •Untreated hypothyroidism or hyperthyroidism (euthyroid or thyroid hrt is acceptable)
- •Current enrolment in another investigational drug or device study
- •There are other conditions present that the investigator feels would be problematic or would restrict or limit the participation for the patient for the entire study period
- •Absolute contraindication to the use of heparin or warfarin
- •Documented intra-arterial thrombus, ventricular thrombus, (less than 6 months after detection of thrombus), tumor or other abnormality that precludes catheter introduction
研究组 & 干预措施
Catheter Ablation
Radiofrequency ablation procedure
干预措施: Catheter Ablation (Procedure)
Medical therapy
Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.
干预措施: Medical therapy (sotalol or amiodarone) (Drug)
结局指标
主要结局
Recurrence of Ventricular Tachycardia
时间窗: 1 year
Number of any appropriate ATPs/shocks and/or presentations of sustained (\>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention
次要结局
- Syncope(1 year)
- Total mortality(1 year)
- Time to First Shock/ATP for VT or to First Presentation of Sustained VT(1 year)
- QOL measures(1 year)
- Sudden cardiac death(1 year)
- Number of hospitalizations(1 year)