Prospective Cohort for the sEcoNDary Prevention of Ventricular Tachycardia in Patients With Cardiomyopathies (END-VT) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,454
- 试验地点
- 3
- 主要终点
- Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes
研究概览
简要总结
Ventricular tachycardia (VT) is a life-threatening cardiac rhythm disturbance which leads to sudden cardiac death (SCD), ventricular fibrillation, electrical storm, hemodynamic collapse, and syncope. VT patients with cardiomyopathy (diseased/scarred cardiac muscle) have the highest risk of SCD (<1-4%) and recurrent VTs (15-35%). Although an implantable cardiac defibrillator (ICD) is the most effective treatment option to prevent SCD, it does not eliminate it. Without VT prevention, recurrent VT and ICD shocks may increase the risk of heart failure and death.
The primary objective is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with ventricular tachycardia (VT) by the creation of a prospective, multicenter, longitudinal cohort. Also, the investigators will evaluate the epidemiology of VT, adherence to guidelines, safety, effectiveness, and cost-effectiveness of current treatment options for secondary prevention of VT in the real-world Canadian VT population.
详细描述
The END-VT study is a multicenter, prospective, longitudinal real-world cohort study of patients with cardiomyopathy-related VT. Patients with ischemic and non-ischemic cardiomyopathy are followed from their first VT event till at least 3 years of follow-up or death, whichever is first. Outcomes of VT events are captured by ICD remote monitoring and are adjudicated by experienced clinical investigators blinded to the center and treatments. The primary objective of END-VT is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with VT. The investigator will also assess the real-world burden of disease, treatment challenges, adherence to guidelines, sex differences, and safety, effectiveness, and cost-effectiveness of VT treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Documented sustained ventricular arrhythmia (>30 seconds as documented by an ECG, cardiac monitor, AED, and/or intracardiac pacemaker/ICD electrograms (EGMs);
- •First (new) diagnosis of VT;
- •Presence of or plan for ICD implant during index hospitalization;
- •Diagnosis of cardiomyopathy (ie. ICM, hypertrophic, dilated, restrictive, arrhythmogenic cardiomyopathy, or other scar),
- •ICD clinic follow-up planned, and
- •Age >18 years old
排除标准
- •Patients with VT due to a reversible cause
结局指标
主要结局
Identification of the best sequence of treatments for a specific patient to optimize long-term outcomes
时间窗: 5 years
次要结局
未报告次要终点