Clinical Trials

Neonates and infants that have cardiac surgery with cardiopulmonary bypass (CPB) for congenital heart disease are at great risk for experiencing life-threatening low cardiac output syndrome (LCOS) in the first 24 hours after surgery. The poor perfusion and inadequate oxygen delivery that occurs may result in multiple organ failure and death. It is LCOS that is responsible for the majority of early postoperative deaths in this population of neonates and infants. Improved pediatric probes placed in peripheral locations using near infrared spectroscopy (NIRS) may permit continuous monitoring of venous saturations reflecting overall perfusion and oxygen balance in the tissues. Following ...

The primary aim of this study is to create a streamlined home monitoring process with modern technologies that are both usable and efficient.  The overall objective of this study is to determine whether or not this application helps improve the efficiency of medical care teams while providing care to interstage participants through the use of usability metrics.  Secondarily, this study introduces a prioritization system that estimates the current risk profile of individual patients to help medical care teams better prioritize their weekly workflows.  Although this mobile application is not a mobile medical device according to the definition of the FDA ...

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) pediatric patients receiving open-label sacubitril/valsartan.

The primary objective of this study is to determine whether a Mayo-developed, highly miniaturized physiologic monitoring instrument can provide early detection of heart failure (HF) in children with congenital or acquired heart disease at risk for or with evidence of heart failure (HF).

The purpose of this study is to determine the change in health outcomes and cardiac structure and function of subjects with HLHS following successful separation from cardiopulmonary bypass and reversal of anticoagulation at the time of elective Stage II Glenn surgical palliation.

The objective of this study is to evaluate the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) delivered into the myocardium of the right ventricle of subjects with Ebstein anomaly undergoing surgical Ebstein repair. Additionally, the potential cardiovascular benefits will also be evaluated. This add-on procedure is anticipated to pose little risk to the subject and has the potential to foster a new strategy that leverages the regenerative capacity of individuals with congenital heart disease during the surgically mandated Ebstein repair.

This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure. The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

The purpose of this registry is to collect data and imagery, to study children and adults under the age of 21 who were born with bicuspid aortic valve disease. Some types of bicuspid aortic valves might be more likely associated with greater disease severity such as the degree of stenosis or valve leakage and possible enlargement of the aorta.

The purpose of this study is to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure. The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.

The purpose of this study is to assess neurodevelopmental and psychosocial outcomes (i.e., executive function, social cognition, psychosocial adjustment, adaptive skills) in children with hypoplastic left heart syndrome (HLHS) who underwent right-ventricle-directed delivery of autologous umbilical cord derived mononuclear cells during staged cardiac surgical palliation, and to compare their outcomes to a matched sample of children with HLHS who did not receive autologous umbilical cord derived mononuclear cells during surgery.

The purpose of this study is to validate novel echocardiographic parameters and algorithms to quantitatively evaluate right ventricular function in patients with Hypoplastic Left Heart Syndrome (HLHS) by applying these methods to previously acquired echocardiographic examinations. 

The purpose of this study is to test the safety and effectiveness of Covered CP Stents to repair or prevent aortic wall injury associated with Coarctation of the Aorta (CoA). Coarctation of the aorta (CoA) is a congenital abnormality producing obstruction to blood flow through the aorta. Coarctation can occur in isolation, in association with bicuspid aortic valve or with major cardiac malformations. CoA accounts for 5-8% of the 8/1000 (4-6/10,000) children born with congenital heart disease. Most CoA is newly diagnosed in childhood; < 25% recognized beyond 10 yrs. CoA is mostly repaired in childhood by surgery or by ...

The purpose of this study is to determine if vasodilators for the lungs can decrease liver stiffness, shown by Magnetic resonance elastography (MRE).  The study also aims to identify any clinical, laboratory, echocardiographic, imaging, and hemodynamic parameters that connect with improved outcomes of cardiac and liver status after starting the pulmonary vasodilators.

The overall objective of this study is to determine whether non-medically trained caregivers can be educated to utilize home monitoring devices paired with our mobile application to collect and store patient-specific information regarding weight, pulse, and oxygen saturation levels for congenital heart disease patients.

The purpose of this study is to compare the difference in the ability to detect blood flow abnormalities between invasive assessments performed at rest versus exercise.