Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Exclusion Criteria20

• Active blood stream infection
• Active or history of endocarditis
• Body weight <2.5kg
• Gestational age <32 weeks at birth
• Complete heart block
• Total Anomalous Pulmonary Venous Return
• Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist
• Presence of an aortopulmonary collateral that is expected to require unifocalization
• Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)
• Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
• Currently participating in an investigational drug study or another device study that would confound the study results
• Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure
• Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)
• Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure
• Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation
• Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure
• Contraindications to peri-procedural anticoagulation
• Known to be non-responsive to aspirin or other antiplatelet therapies
• Known hypersensitivity or allergy to Nickel
• Known hypersensitivity to contrast media that cannot be adequately pre-medicated