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RECRUITING Not applicable ClinicalTrials.gov

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Sponsor: Starlight Cardiovascular Inc • ClinicalTrials.gov ID: NCT07114718

Registry updated: 2026-09-14
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Description

Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System. The study device is a stent that is designed to maintain patency of the Ductus Arteriosus for children who need blood flow through that part of the heart.

Interventions

  • Ductus Arteriosus Stent (Device)
    The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Eligibility criteria

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 circulation requiring 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 treating interventionalist 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 coronary circulation 11. Currently participating in an investigational drug study or another device study that would confound the study results 12. Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure 13. Major co-morbidities which, in the opinion of the investigator, would negatively alter 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 or within 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 eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation 16. 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 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

Conditions

Congenital Heart Disease Congenital Heart Disease (CHD)

Locations

  • UCLA Mattel Children's — Los Angeles, California, United States
  • Rady Children's Hospital San Diego — San Diego, California, United States
  • Leland Stanford Junior University — Stanford, California, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • Boston Children's Hospital — Boston, Massachusetts, United States
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
  • Nationwide Children's Hospital — Columbus, Ohio, United States
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Texas Children's Hospital - Baylor College of Medicine — Houston, Texas, United States
  • Seattle Children's Hospital — Seattle, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record