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Clinical Trials in the USA / NCT07114718
Recruiting

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

NCT07114718 · tracked via the Priya Life Science USA tracker
Sponsor
Starlight Cardiovascular Inc
Phase
N/A
Started
2026-01-16
Last updated
2026-09-14

Condition(s) studied

Congenital Heart DiseaseCongenital Heart Disease (CHD)

Investigational drug(s) / intervention(s)

Ductus Arteriosus Stent

Ductus Arteriosus Stent: The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Minute
Max age
6 Months
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
UCLA Mattel Children's Los Angeles California Recruiting
Rady Children's Hospital San Diego San Diego California Not Yet Recruiting
Leland Stanford Junior University Stanford California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Boston Children's Hospital Boston Massachusetts Not Yet Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Nationwide Children's Hospital Columbus Ohio Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Texas Children's Hospital - Baylor College of Medicine Houston Texas Recruiting
Seattle Children's Hospital Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07114718 on ClinicalTrials.gov ↗ ← All trials in the USA