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A Study of the Effect of Sildenafil for Improvement of Hepatic Fibrosis after the Fontan Heart Surgery
Rochester, MN
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.
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National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
Rochester, MN
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.
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Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures
Rochester, MN
The purpose of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.
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Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Rochester, MN
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart. The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack ...
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A Study to Evaluate Aortic Dilatation in Patients with Conotruncal Abnormalities
Rochester, MN
The purpose of this study is to assess operative and postoperative outcomes after aortic valve surgery, evaluate for changes in ascending aorta diameter by comparing pre-operative CT imaging to measurements on follow-up imaging, and examine late outcomes and functional status during the follow-up period with specific focus on mortality, need for re-operation and incidence of aortic dissection.
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A Study to Evaluate Neurodevelopmental Outcomes in Children with Hypoplastic Left Heart Syndrome After Delivery of Autologous Umbilical Cord Derived Mononuclear Cells During Cardiac Surgery
Rochester, MN
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.
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A Study to Analyze Intramyocardial Injection Mononuclear Cells during Fontan Surgical Palliation of Congenital Heart Disease
Rochester, MN
This study aims to evaluate the safety of intramyocardial delivery of autologous umbilical cord blood-derived mononuclear cells during Fontan surgical palliation and measure surrogate markers of myocardial protection within a non-randomized study design to obtain prospective data from treatment and control populations.