Pediatric Cardiology Clinical Trials

Study Title Description
ASCENT ASD Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect  Prospective, three-stage, single arm, multi-site, clinical investigation evaluating the safety and efficacy of the reSept ASD Occluder in treating clinically significant secundum ASD. Outcomes/endpoints of the clinical investigation will be compared with established performance goals for FDA approved transcatheter secundum ASD occluders
 14-PR-1101 CorMatrix Cor TRICUSPID ECM Valve Replacement Study CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional tricuspid heart valves. This Early Feasibility Study is proposed to obtain initial insights into the ability to successfully implant the Tricuspid Valve, the clinical safety of the device, and whether the device performs its intended use. The study is a multi-center, prospective, single-arm, Early Feasibility Study (EFS) of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve
AVNRT Pathway Ablation Treatment Study of AV Node Reentry Tachycardia (AVNRT) Compare the effectiveness and safety of two techniques for modification of slow AV nodal pathway conduction underlying AVNRT: 1) New Ablation Technique, low voltage and wave front collision mapping vs. 2) the Standard Ablation Technique, an anatomical/electrogram approach.
Autonomic Tone
Association of Autonomic Tone and Markers of Inflammation in Patients with Congenital Heart Disease  
4D-Flow Assessment of Fontan hemodynamics using 4D flow cardiac magnetic resonance imaging  
XPLORE2 Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study This is a multi-center prospective, single-arm, nonrandomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract correction or reconstruction due to congenital heart malformations.
ECHO-E Integrating Multi-parametric Echocardiography with Computer Assisted Analyses in Detection for Early Allograft Rejection in Pediatric Heart Transplant Recipients: A Pilot Prospective Multicenter Trial  
 Heart Failure
Natural History Study in Pediatric Patients With MYBPC3 Mutation-associated Cardiomyopathy (MyCLIMB)
The objective of this study is to collect information on patients with cardiomyopathy (CM) due to mutations in the MYBPC3 gene, to evaluate their disease course, burden of illness, risk factors for this disease, and the quality of life (QoL). This study will also collect information on treatments, procedures and outcome in infants and children up to 18 yrs who have this mutation. 
Long-Term outcomes after the Multisystem Inflammatory Syndrome In Children The objective of this study is to determine the spectrum and time course of coronary artery involvement, left ventricular (LV) systolic function, and arrhythmias or conduction system disturbances within the first year from illness onset, and to define associated clinical and laboratory factors.