Optical Tissue Identification for Myocardial Architecture (OPTIMA Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rate of new conduction disorders
研究概览
简要总结
The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
详细描述
This is an interventional randomized controlled study to investigate the use of fiberoptic confocal microscopy (FCM) imaging for avoidance of conduction abnormalities during repair of common congenital heart defects. Study results will be compared to a cohort of similar surgical patients following standard surgical procedures where FCM was not used. We will analyze pre-and postoperative ECGs to identify conduction abnormalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects and the physician reading ECGs will be blinded.
入排标准
- 年龄范围
- 30 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 days to less than 18 years old
- •Patients with planned surgical repair of:
- •Ventricular septal defect (VSD)
- •Complete atrioventricular canal (CAVC)
- •Tetralogy of Fallot (ToF) with pulmonary stenosis
排除标准
- •Prior history of adverse reaction to fluorescein sodium
- •Prior history of renal failure or abnormal renal function
- •Baseline PR interval > 220 msec or 98% for age
- •Baseline HR > 98% for age
- •Underlying genetic syndrome associated with progressive AV block or sinus node dysfunction (e.g. Holt-Oram or NKX2.5)
- •Any surgical repair that requires staging or palliation
- •Pregnant or lactating
- •Exclusions specific to type of surgical repair
- •Apical muscular VSD
- •ToF with pulmonary atresia
研究组 & 干预措施
Imaging cohort
Up to 5mL of 1:1000 dilute fluorescite will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes. The system will be used to assist the investigator with the operative course.
干预措施: Fluorescite (Drug)
Imaging cohort
Up to 5mL of 1:1000 dilute fluorescite will be applied to cardiac tissue prior to imaging with Cellvizio 100 Series System with Confocal Miniprobes. The system will be used to assist the investigator with the operative course.
干预措施: Cellvizio 100 Series System with Confocal Miniprobes (Device)
结局指标
主要结局
Rate of new conduction disorders
时间窗: Immediately post-surgery
Rate of new conduction disorders post-surgery will be determined by electrophysiologist read and compared between the two groups
次要结局
- Residual lesion score (RLS) at discharge(Surgery to discharge (approximately 5 days))
- Change in QRS interval(Approximately 5 days post-surgery and 1 year post-surgery)
- Degree of heart block(1 year post-surgery)
- Pacemaker implantation(1 year post-surgery)
- Time to temporary pacing wire removal prior to discharge(Surgery to discharge (approximately 5 days))
- Need for repeat bypass(1 day)
- Adverse events(1 year post-surgery)
- Ease of use(1 day)
- Change in PR interval(1 year post-surgery)
- Change in QTc interval(1 year post-surgery)
研究者
Aditya Kaza
Associate in Cardiac Surgery
Boston Children's Hospital