Lifeline ductus arteriosus stent for infants with ductal-dependent circulation

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

The trial will test whether the Lifeline ductus arteriosus stent safely keeps the ductus arteriosus open in infants under 6 months who need ductal-dependent pulmonary blood flow.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 1 Minute to 6 Months
• Sex: All
• Sponsor: Starlight Cardiovascular Inc (Industry-sponsored)
• Locations: 8 sites (Los Angeles, California and 7 other locations)
• Trial ID: NCT07114718 on ClinicalTrials.gov

What this trial studies

Starlight Cardiovascular is sponsoring a prospective, multicenter trial to test the safety and effectiveness of the Lifeline Ductus Arteriosus Stent System in infants with ductal-dependent pulmonary circulation. Infants under 6 months who require prostaglandin infusion and meet device size criteria will have the stent placed percutaneously and be followed for clinical outcomes. The study will collect safety and effectiveness endpoints across several pediatric cardiac centers to support a potential FDA approval. Patients with certain anatomic variations, active infections, very low birth weight, or other exclusion criteria will not be enrolled.

Who should consider this trial

Good fit: Ideal candidates are infants under 6 months with congenital heart defects causing ductal-dependent pulmonary circulation who are receiving prostaglandins, weigh at least 2.5 kg, were born at ≥32 weeks gestation, and require a 3.5 mm or 4.0 mm stent (16–28 mm length).

Not a fit: Infants with active bloodstream infection or endocarditis, body weight below 2.5 kg, gestational age under 32 weeks, complete heart block, nonconfluent pulmonary arteries, RV-dependent coronary circulation, or other anatomic features judged unsuitable for stenting are unlikely to benefit.

Why it matters

Potential benefit: If successful, the device could maintain ductal blood flow without prolonged prostaglandin therapy or immediate surgical shunt, helping stabilize infants until definitive repair or palliation.

How similar studies have performed: Ductus arteriosus stenting has been performed successfully at specialized centers and reported in the literature, but the Lifeline system is a device-specific IDE pathway seeking prospective data for FDA approval.

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

Where this trial is running

Los Angeles, California and 7 other locations

• UCLA Mattel Children's — Los Angeles, California, United States (Recruiting)
• Leland Stanford Junior University — Stanford, California, United States (Recruiting)
• Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
• Boston Children's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
• Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
• Texas Children's Hospital - Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Mary Beth Tate, BSBE-MBA

Conditions Congenital Heart Disease; Ductus Arteriosus Stent; pediatric stent; Lifeline Stent