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Clinical Studies


Closed for Enrollment

  • Care Provider Satisfaction in Mobile Monitoring of Children with Single Ventricle Congenital Heart Disease Rochester, Minn.

    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 guidance documents (not requiring IDE), documenting the feasibility of this mobile application to be used within the context of standardized home monitoring programs will inform the use of this technology into clinical practice. 

  • Caregiver Monitoring of Children with Congenital Heart Disease Rochester, Minn.

    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.

  • Collection of Discarded Neonatal Thymus Tissue for Use in Preclinical Research Rochester, Minn.

    Thymus tissue is standardly removed during neonatal congenital cardiac surgery. The collection of this tissue poses no additional risk to subjects. TRAG’s standard operating procedures will be followed to prepare, store, and provide the discarded tissue to Dr. Tuggle. An internal database will be used to record consent, date of collection, and date of shipment. After collection of the thymus tissue, there will be no further contact with subjects or families.  There will be no results to report and no information will become part of the subject’s medical record.

  • Genetic Investigations in Hypoplastic Left Heart Syndrome Rochester, Minn.

    The primary objective of the study is to utilize comprehensive, family-centered genomic screening strategies - chromosomal microarray (CMA) and whole genome sequencing (WGS) - to discover the genetic bases for Hypoplastic Left Heart Syndrome (HLHS), a severe type of congenital heart disease characterized by underdevelopment of left heart structures.

  • National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease (NPC-QIC) Rochester, Minn.

    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.