Prospective Studies and Trials

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Trial name: Fontan Imaging Biomarkers (FIB) Study
Description: This is a cross-sectional study analyzing the non-invasive measures of ventricular systolic function, diastolic function, and serum/urine biomarkers in patients after the Fontan operation.
Enrollment goal: 100
Contacts: Sunil Ghelani, MD, sunil.ghelani@cardio.chboston.org and Rahul Rathod, MD, rahul.rathod@cardio.chboston.org

Trial name: A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
Description: To determine the safety of a DEX loading dose/infusion regimen as part of a balanced general anesthetic/sedative strategy for neonates/infants undergoing corrective congenital cardiac surgery using cardiopulmonary bypass.
Enrollment goal: total of 106 patients from 4 centers
Contact: Juan C. Ibla, MD, juan.ibla@childrens.harvard.edu, 617-355-6225

Trial name: PCGC (Pediatric Cardiac Genetic Consortium): The Genomic Basis of Congenital Heart Disease and Neurodevelopmental Outcomes
Description: Innovative genomic techniques will be used to uncover new genetic causes of congenital heart disease. The project will also explore how genetic mutations and variants affect child development and the central nervous system.
Enrollment goal: 2000 (consortium-wide)
Contact: Judith Geva, Research Coordinator, judith.geva@cardio.chboston.org, 617-355-4979

Trial name: Validation of the Residual Lesion Score for Congenital Heart Surgery. (A pediatric Heart Network Study)
Description: This multicenter prospective study will validate the RLS as a tool to predict early and mid-term outcomes for five common congenital cardiac operations. The RLS study will develop the first validated tool for measurement of residual lesions following congenital heart surgery.
Enrollment goal: total of 1250 subjects across 17 centers (250 subjects each in the following procedural categories: CAVSD repair, TOF/PS repair, ASO, Norwood, and Arch VSD repair)
Contacts: Meena Nathan, MD, meena.nathan@cardio.chboston.org, 617-355-4308 and Jane Newburger, MD, MPH, jane.newburger@cardio.chboston.org, 617-355-5427

Title: A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition from Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years with Pulmonary Arterial Hypertension
Description: This study offers oral treprostinil as an add-on therapy for pediatric PAH patients and will assess the safety, tolerability and pharmacokinetics of this drug. Eligible patients may be transitioned from IV Remodulin or inhaled prostacyclin or they may be de novo prostacyclin patients.
Enrollment goal: 40 nationwide, 4-8 at Boston Children’s
Contact: Mary Mullen, MD, PhD, mary.mullen@cardio.chboston.org, 617-355-7866

Title: Surgical Planning with 3D Printed Cardiac Models in Patients with Malformations that Require Biventricular Repair
Description: The primary aim of this prospective, randomized trial is to assess the correlation between pre-operative surgical planning via inspection of a 3D printed cardiac model with reduced OR time.
Enrollment goal: 30
Contacts: Bre Piekarski, RN, BSN, breanna.piekarski@cardio.chboston.org, 617-919-4457 and PI: Sitaram Emani, MD, sitaram.emani@cardio.chboston.org, 617-355-7932

Title: Evaluation of Coagulation Testing in Patients Undergoing Cardiac Surgery
Description: The aim of this prospective study is to use discarded blood from routine laboratory testing in neonates to assess the efficacy of new technology for coagulation assessment that is faster and uses less blood than current available testing.
Enrollment goal: 100
Contacts: Bre Piekarski, RN, BSN, breanna.piekarski@cardio.chboston.org, 617-919-4457 and PI: Sitaram Emani, MD, sitaram.emani@cardio.chboston.org, 617-355-7932 

Title: Determining the Natural and “Unnatural” History of Anomalous Aortic Origin of a Coronary Artery with an Interarterial Course (AAOCA): Establishing a Multi-Institutional Registry
Description: The purpose of the study is to determine the outcome of surgical intervention versus observation in children and young adults with AAOCA. To do this we will create a risk stratification model utilizing a large multi-institutional registry with the Congenital Heart Surgeon Society (CHSS).
Enrollment goal: 200
Contacts: Bre Piekarski, RN, BSN, breanna.piekarski@cardio.chboston.org, 617-919-4457 and PI: Meena Nathan, MD, meena.nathan@cardio.chboston.org, 617-355-4308

Title:  COMMENCE TRIAL Prospective, Non‐randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Description: The COMMENCE pulmonary trial is to assess the safety and effectiveness of the Edwards Pericardial Bioprosthesis valve in the pulmonary position in patients 5 years or older requiring replacement of their native or prosthetic pulmonary valve.  Clinical data will be collected for 5 years after enrollment is completed. 
Enrollment goal: 100 nationwide, 30-40 from Boston Children’s
Contact:  Christopher W. Baird, MD.  (Chris.Baird@cardio.chboston.org, 617-355-1914)

Title:  HALO Clinical Study: A single arm, prospective, non-randomized, multi-center clinical investigation of the St. Jude’s Medical Masters HP 15mm Rotatable Mechanical Heart Valve (MHV)
Description: Currently, commercially available mechanical mitral valves range in sizes 16 mm to 37 mm. A portion of the pediatric population would benefit from the availability of a smaller valve.  This study plans to evaluate the safety and durability of 15 mm St. Jude Masters Heart Valve intended for mitral valve replacement in patients less than five years of age.
Enrollment goal:  20 nationwide
Contact:  Christopher W. Baird, MD.  (Chris.Baird@cardio.chboston.org, 617-355-1914)

Title:  A prospective single center study of Aortic valve reconstruction using the Ozaki technique
Description: The Ozaki procedure is a technique in which aortic valve reconstruction replaces three aortic valve cusps by using gluteraldehyde treated autologous pericardium and can be applied to a wide spectrum of aortic valve disease. This is considered reconstruction rather than replacement as there are no foreign materials and limited need (ASA) for postoperative anticoagulation.
Enrollment goal:  50
Contact:  Christopher W. Baird, MD.  (Chris.Baird@cardio.chboston.org, 617-355-1914)

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