Predicting Arrhythmogenic Risk in Congenital Heart Patients: the PRECISION Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of patients with supraventricular tachycardia
研究概览
简要总结
In this research study we want to learn more about abnormal heart rhythm after cardiac surgery in children. These abnormal heart rhythms, also called arrhythmias, may occur due to several reasons after cardiac surgery. They can be due to abnormal electrical pathway or an irritable area of the heart that stimulates abnormal impulses. Regardless of the cause, arrhythmias after cardiac surgery can be a problem, extending the hospital stay, requiring additional medications and even leading to cardiac arrest.
Current practice is to monitor for arrhythmias after cardiac surgery, and to treat them if they occur. With this research, we want to investigate whether we can identify patients who will develop arrhythmia, and treat them before they occur.
详细描述
This is a prospective, randomized controlled trial of provocative electrophysiology testing and prophylactic treatment of inducible SVT versus expectant management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged < 18 years of age on admission to the cardiac intensive care unit following cardiac surgery with a predicted probability of supraventricular tachycardia >10%
排除标准
- •Patients following orthotopic heart transplant, ventricular assist device implantation, primary extracorporeal membrane oxygenation cannulation, pacemaker or implantable cardioverter-defibrillator implantation or sympathectomy
- •Patients on antiarrhythmic medication at the time of surgery
- •Patients with atrioventricular conduction disease (1st degree atrioventricular block with PR interval greater than 200 ms, 2nd degree atrioventricular block or complete heart block)
- •Patients with severe ventricular dysfunction in whom therapy with beta-blocker or sotalol is deemed contra-indicated by the primary team
- •Patients with absent or non-functioning atrial pacing wires
结局指标
主要结局
Number of patients with supraventricular tachycardia
时间窗: Through hospital discharge after cardiac surgery, or up to 90 days
Number of days post-operatively at time of supraventricular tachycardia
次要结局
- Number of days post-operatively in the intensive care unit(Though hospital discharge)
- Number of patients with adverse events related to antiarrhythmic treatment(Through hospital discharge after cardiac surgery, or up to 90 days)
- Number of patients with supraventricular tachycardia after hospital discharge(12 months)
- Number of patients with sustained supraventricular tachycardia(Through hospital discharge after cardiac surgery, or up to 90 days)
- Number of patients with other tachyarrhythmias(Through hospital discharge after cardiac surgery, or up to 90 days)
- Number of days post-operatively at time of extubation(Through hospital discharge after cardiac surgery, or up to 90 days)
- Number of patients with major adverse cardiac events (including need for CPR, ECMO or death)(Through hospital discharge after cardiac surgery, or up to 90 days)
- Number of patients with adverse events related to provocative electrophysiology testing(Through hospital discharge after cardiac surgery, or up to 90 days)
- Number of days in the hospital(Through hospital discharge after cardiac surgery, or up to 90 days)
研究者
Audrey Dionne
Pediatric Cardiologist
Boston Children's Hospital