Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular Inc
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.
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.
Eligibility
- Age range
- 1–0 years
- Sex
- All
- Healthy volunteers
- No
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…
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'sLos Angeles, California
- Leland Stanford Junior UniversityStanford, California
- Children's Hospital ColoradoAurora, Colorado
- Boston Children's HospitalBoston, Massachusetts
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Nationwide Children's HospitalColumbus, Ohio