Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Inclusion Criteria:

1. Parental or legal authorized representative provide consent for study enrollment

2. Infants < 6 months of age

3. Diagnosis of congenital heart defect with ductal-dependent pulmonary circulationrequiring infusion of prostaglandins

4. Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm

Exclusion Criteria:

1. Active blood stream infection

2. Active or history of endocarditis

3. Body weight <2.5kg

4. Gestational age <32 weeks at birth

5. Complete heart block

6. Total Anomalous Pulmonary Venous Return

7. Anatomic variation judged to be inappropriate for ductal stenting per the treatinginterventionalist

8. Presence of an aortopulmonary collateral that is expected to require unifocalization

9. Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin)or bilateral patent ductus arteriosus (PDA)

10. Pulmonary atresia with intact ventricular septum with RV-dependent coronarycirculation

11. Currently participating in an investigational drug study or another device studythat would confound the study results

12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assistdevice (VAD), or dialysis prior to ductal stenting procedure

13. Major co-morbidities which, in the opinion of the investigator, would negativelyalter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)

14. Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy,aortic arch intervention, or right ventricular outflow tract intervention) during orwithin 24 hours prior to the ductus arteriosus stenting procedure

15. Patient who, at the time of enrollment, is deemed not to be a candidate for eventualstage II palliation of single ventricle heart disease, complete surgical repair, nortranscatheter treatment with resultant biventricular circulation

16. Patient who does not plan to return to the enrolling center or another participatingcenter for stage II palliation, complete surgical repair, or definitivecatheterization procedure

17. Contraindications to peri-procedural anticoagulation

18. Known to be non-responsive to aspirin or other antiplatelet therapies

19. Known hypersensitivity or allergy to Nickel

20. Known hypersensitivity to contrast media that cannot be adequately pre-medicated