Clinical Trials Snapshot

At any given time, Boston Children’s Hospital has hundreds of clinical trials underway. The following is a snapshot of just some of the clinical trials currently underway through Boston Children’s Heart Center.

Coarctation of the Aorta Stent Trial Continued Access (COAST II CA)

This study will provide continued access to the Covered CP Stent as primary therapy for prevention of aortic wall injury in patients with native or recurrent coarctation, or for repair of aortic wall injury occurring as a late complication of prior coarctation repair.

Contact: Lisa Bergersen, MD, MPH

GORE® Septal Occluder (GSO)

This study will evaluate the safety and efficacy of this device for the transcatheter closure of ostium secundum atrial septal defects. The data obtained will be used to compare outcomes with this next generation device to those in prior studies using the GORE® HELEX® Septal Occluder.

Contact: Lisa Bergersen, MD, MPH

Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

This study will assess in vivo loading conditions of a TPV device for product development specifications and summarize five-year clinical outcomes.

Contact: Lisa Bergersen, MD, MPH

Pulmonary Artery Repair with Covered Stents (PARCS)

This study will evaluate the safety and efficacy of a Covered CP Stent in repairing RV-PA conduit disruption during transcatheter pulmonary valve placement with Melody® TPV.

Contact: Lisa Bergersen, MD, MPH

Other Research Highlights

Selected from among 141 publications by Heart Center faculty between October 1, 2013 and May 1, 2014.

Dusenbery SM, Jerosch-Herold M, Rickers C, Colan SD, Geva T, Newburger JW, Powell AJ. Myocardial extracellular remodeling is associated with ventricular diastolic dysfunction in children and young adults with congenital aortic stenosis. J Am Coll Cardiol. 2014;63(17):1778-85.

Teele SA, Salvin JW, Barrett CS, Rycus PT, Fynn-Thompson F, Laussen PC, Thiagarajan RR. The association of carotid artery cannulation and neurologic injury in pediatric patients supported with venoarterial extracorporeal membrane oxygenation. Pediatr Crit Care Med. 2014;15(4):355-61.

Saleeb SF, Newburger JW, Geva T, Baird CW, Gauvreau K, Padera RF, Del Nido PJ Borisuk MJ, Sanders SP, Mayer JE. Accelerated degeneration of a bovine pericardial bioprosthetic aortic valve in children and young adults. Circulation. 2014.

Newburger JW, Sleeper LA, Frommelt PC, Pearson GD, Mahle WT, Chen S, Dunbar-Masterson C, Mital S, Williams IA, Ghanayem NS, Goldberg CS, Jacobs JP, Krawczeski CD, Lewis AB, Pasquali SK, Pizarro C, Gruber PJ, Atz AM, Khaikin S, Gaynor JW, Ohye RG; for the Pediatric Heart Network Investigators. Transplant-free survival and interventions at 3 years in the single ventricle reconstruction trial. Circulation. 2014.

Singh TP, Milliren CE, Almond CS, Graham D. Survival benefit from transplantation in patients listed for heart transplantation in the United States. J Am Coll Cardiol. 2014;63(12):1169-78.

Rathod RH, Prakash A, Kim YY, Germanakis IE, Powell AJ, Gauvreau K, Geva T. Cardiac magnetic resonance parameters predict transplant-free survival in Fontan patients. Circ Cardiovasc Imaging. 2014.

Myers PO, del Nido PJ, Emani SM, Marx GR, Baird CW. Valve-sparing aortic root replacement and remodeling with complex aortic valve reconstruction in children and young adults with moderate or severe aortic regurgitation. J Thorac Cardiovasc Surg. 2014.

Miyake CY, Teele SA, Chen L, Motonaga KS, Dubin AM, Balasubramanian S, Balise RR, Rosenthal DN, Alexander ME, Walsh EP, Mah DY. In-hospital arrhythmia development and outcomes in pediatric patients with acute myocarditis. Am J Cardiol. 2014;113(3):535-40.

Valente AM, Gauvreau K, Assenza GE, Babu-Narayan SV, Schreier J, Gatzoulis MA, Groenink M, Inuzuka R, Kilner PJ, Koyak Z, Landzberg MJ, Mulder B, Powell AJ, Wald R, Geva T. Contemporary predictors of death and sustained ventricular tachycardia in patients with repaired tetralogy of Fallot enrolled in the INDICATOR cohort. Heart. 2014;100(3):247-53.

Hofferberth SC, Cecchin F, Loberman D, Fynn-Thompson F. Left thoracoscopic sympathectomy for cardiac denervation in patients with life-threatening ventricular arrhythmias. J Thorac Cardiovasc Surg. 2014;147(1):404-9.

McLellan MC, Gauvreau K, Connor JA. Validation of the Cardiac Children’s Hospital Early Warning Score: An Early Warning Scoring Tool to Prevent Cardiopulmonary Arrests in Children with Heart Disease. Congenit Heart Dis.2014;9(3):194