Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 555
- 试验地点
- 13
- 主要终点
- Proportion of Patients Who Died or Received a Heart Transplant
研究概览
简要总结
This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation at 12 months post randomization; and compare the effect of the two shunts on intensive care unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental outcome.
详细描述
BACKGROUND:
Hypoplastic left heart syndrome (HLHS) and related single right ventricle anomalies are the highest risk congenital cardiovascular malformations. Surgical repair begins with the Norwood procedure during the newborn period, a stage II procedure at 4 to 6 months of age, and Fontan procedure at 18 to 36 months. The Norwood procedure remains one of the highest risk procedures in congenital heart surgery. A few small nonrandomized studies of a novel approach to the Norwood procedure have reported improved outcomes. This new approach uses a RV-to-PA shunt to provide pulmonary blood flow rather than the standard MBTS. This multi-center, randomized clinical trial will evaluate early and intermediate-term outcomes for patients undergoing a Norwood procedure with either the RV-to-PA shunt or the MBTS.
This study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:
Hospital for Sick Children, Toronto, Canada
Children's Hospital Boston, Boston, MA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
- •Planned Norwood procedure
- •Informed consent of parent(s) or legal guardian
排除标准
- •Single, morphologic left ventricle anomaly
- •Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
- •Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint
研究组 & 干预措施
MBTS
Blalock-Taussig pulmonary artery shunt
干预措施: Blalock-Taussig pulmonary artery shunt (Procedure)
RVPAS
Right ventricular to pulmonary artery shunt
干预措施: Right ventricular to pulmonary artery shunt (Procedure)
结局指标
主要结局
Proportion of Patients Who Died or Received a Heart Transplant
时间窗: Measured at 12 months
The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.
次要结局
- Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial(From Randomization to the End of the Trial, an average of 32 months)
- Angiographic Findings: Left Pulmonary Artery Size(Measured pre-stage II surgery, on average 26 days prior to stage II palliation)
- Angiographic Findings: Right Pulmonary Artery Size(Measured pre-stage II surgery, on average 26 days prior to stage II palliation)
- Unintended Cardiovascular Interventional Procedures(From Randomization to 12 months)
- Complications: Total Number Experienced During Norwood Hospitalization(Norwood Hospitalization, an average of 36 days)
- Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge(From Norwood Discharge to Stage II discharge, an average of 4.2 months)
- Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)(Measured post-Norwood, an average of 17 days post-Norwood)
- Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA(Measured at 14 months of age)
- Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA(Measured at 14 months of age)
- Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction(Measured at 14 months of age)
- Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age(From Stage II Discharge to 14 Months of Age, an average of 8.9 months)
- Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA(Measured pre-stage II surgery, an average of 15 days pre-stage II surgery)
- Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA(Measured post-Norwood, an average of 17 days post-Norwood)
- Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA(Measured pre-stage II surgery, an average of 15 days pre-stage II surgery)
- Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction(Measured post-Norwood, an average of 17 days post-Norwood)
- Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction(Measured pre-stage II surgery, an average of 15 days pre-stage II surgery)