RecruitingNot ApplicableNCT07114718

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Sponsor

Starlight Cardiovascular Inc

Enrollment

35 participants

Start Date

Jan 16, 2026

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Ductus Arteriosus Stent for people with congenital heart disease and congenital heart disease (chd). The study is currently recruiting participants at 8 locations. People eligible for this study include aged 1 Minute to 6 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDuctus Arteriosus Stent

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

Locations(8)

UCLA Mattel Children's

Los Angeles, California, United States

Leland Stanford Junior University

Stanford, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Texas Children's Hospital - Baylor College of Medicine

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07114718

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