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To demonstrate the proof of principle and initial clinical safety of the CorMatrix ECM Tricuspid Valve and increase the efficiency of the device development process by identifying appropriate modifications to the implant procedure or the device.
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 the plan is to create a registry of AAOCA subjects that will enable us to develop a risk stratification model utilizing a large multi-institutional registry under the auspices of the Congenital Heart Surgeons’ Society (CHSS).
The purpose of this study is to compare the addition of muscle tissue removal versus membrane removal alone in patients with discrete subaortic stenosis to assess the long term rate of repeat left ventricle outflow obstruction.
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.
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