NCT07114718 Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
| NCT ID | NCT07114718 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Starlight Cardiovascular Inc |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2026-01-16 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07114718 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 6 Months, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07114718 currently recruiting?
Yes, NCT07114718 is actively recruiting participants. Contact the research team at marybeth.tate@globalmedicaldeviceconsultants.com for enrollment information.
Where is the NCT07114718 trial being conducted?
This trial is being conducted at Los Angeles, United States, Stanford, United States, Aurora, United States, Boston, United States and 4 additional locations.
Who is sponsoring the NCT07114718 clinical trial?
NCT07114718 is sponsored by Starlight Cardiovascular Inc. The trial plans to enroll 35 participants.