Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 275
- 主要终点
- Mortality
研究概览
简要总结
The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:
To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.
To aid surgeons in envisioning different surgical approaches for each individual patient.
To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.
Participants will:
Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.
Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.
详细描述
The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups.
Patient and surgeon will both be notified which group they have been assigned to.
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are pediatric patients ages 0-17 with a congenital heart disease (CHD) diagnosis of 1) congenitally corrected transposition of the great arteries (cc-TGA) with ventricular septal defect (VSD), 2) double outlet right ventricle (DORV) with remote VSD, or 3) other single ventricle conditions.
排除标准
- •Adult patients with CHD.
结局指标
主要结局
Mortality
时间窗: At date of hospital discharge or up to 30 days post-operation
Alive or deceased post-operative
次要结局
- Number of cardioplegic arrest(Up to 10 hours)
- Mortality(Latest follow-up exam up to 3 years post-operation)
研究者
Alison Lesley Marsden
DOUGLASS M. AND NOLA LEISHMAN PROFESSOR OF CARDIOVASCULAR DISEASES, PROFESSOR OF PEDIATRICS (CARDIOLOGY) AND OF BIOENGINEERING AND, BY COURTESY, OF MECHANICAL ENGINEERING
Stanford University