NCT07114718

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Starlight Cardiovascular Inc · Industry
• Sex: All
• Age: 1 Minute – 6 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the LifelineTM Ductus Arteriosus Stent System. The purpose of the study is to determine whether the Ductus Arteriosus Stent System demonstrates safety and effectiveness for patients who require ductal patency and merits Food and Drug Administration (FDA) approval.

Conditions

• Congenital Heart Disease
• Congenital Heart Disease (CHD)

Interventions

Type	Name	Description
DEVICE	Ductus Arteriosus Stent	The eligible subjects will proceed to implantation of the Lifeline Ductus Arteriosus Stent to maintain patency of the PDA.

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-10-01
• Completion: 2028-04-01
• First posted: 2025-08-11
• Last updated: 2026-02-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study