RecruitingNot ApplicableNCT07114718

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Sponsor

Starlight Cardiovascular Inc

Enrollment

35 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Congenital Heart Disease Congenital Heart Disease (CHD)

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

Min Age: 1 MinuteMax Age: 6 Months

Inclusion Criteria4

Parental or legal authorized representative provide consent for study enrollment
Infants \< 6 months of age
Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm

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