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Recruiting
NCT07114718
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Conditions: Congenital Heart Disease, Congenital Heart Disease (CHD)
Sex: All
Ages: 1 Minute – 6 Months
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Starlight Cardiovascular Inc
Location: UCLA Mattel Children's Los Angeles California
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 \
Source: ClinicalTrials.gov (NCT07114718). StuddyBuddy aggregates publicly available trial information.
