Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Ventricular Arrhythmias
研究概览
简要总结
A chronic total occlusion (CTO) is common in patients with coronary artery disease. CTO recanalization has been shown to improve survival in comparison to failed CTO recanalization. Whether this is related to ventricular arrhythmias (VA) is unknown. The purpose of this pilot study is to evaluate the incidence of VA after successful CTO recanalization and in those with failed CTO recanalization or untreated CTO. Patients will be monitored using an insertable cardiac monitor.
详细描述
Rationale: Successful chronic total occlusion (CTO) recanalization has been associated with improved long-term survival. Furthermore, CTO is an independent predictor for the occurrence of ventricular arrhythmias (VA) in patients with ischemic cardiomyopathy and implantable cardioverter defibrillators (ICDs). One may speculate that a successful CTO recanalization may provide electrical stability. However, no data are available on the incidence of sustained VA in this patient population.
Objective: The objective of the present pilot study is to assess the incidence of sustained VA in 2 CTO groups: patients with successful percutaneous CTO recanalization (group A), patients with failed percutaneous CTO recanalization or untreated CTO (group B).
Study design: Pilot study of patients with CTO.
Study population: A total of 90 patients will be enrolled with a maximum of 45 patients in each arm.
Intervention: A Medtronic Reveal LINQ™ Insertable cardiac monitor (ICM) will be implanted in every patient to continuously monitor heart rhythm during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- 未提供
排除标准
- •Patients who are potential candidates for an ICD according to the 2015 ESC guidelines.
- •Patients who have a cardiac implantable electrical device (CIED) (e.g., pacemaker, ICD).
- •Patient has reduced immune function or is otherwise at high risk for infection.
- •Patient has had a recent (within 30 days) or otherwise unresolved infection.
- •Known pregnancy at time of inclusion.
- •Patient has severe co-morbidity that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life expectancy (i.e., less than one year).
结局指标
主要结局
Ventricular Arrhythmias
时间窗: 3 years after ICM implantation
Sustained ventricular tachycardia (\>30 s) or ventricular fibrillation
次要结局
未报告次要终点
研究者
Sing-Chien Yap, MD, PhD
Principal investigator
Erasmus Medical Center