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New treatment option for Congenital Heart Disease
Official title Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
ClinicalTrials.gov ID: NCT07114718
What this study is testing
- What it's testing
- Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 6
You may be able to join if
- Parental or legal authorized representative provide consent for study enrollment
- Infants \< 6 months of age
- Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
- Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm
You likely can't join if
- Active blood stream infection
- Active or history of endocarditis
- Body weight \<2.5kg
- Gestational age \<32 weeks at birth
- Complete heart block
- Total Anomalous Pulmonary Venous Return
See the full eligibility criteria
- Parental or legal authorized representative provide consent for study enrollment
- Infants \< 6 months of age
- Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
- Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm
- Active blood stream infection
- Active or history of endocarditis
- Body weight \<2.5kg
- Gestational age \<32 weeks at birth
- Complete heart block
- Total Anomalous Pulmonary Venous Return
- Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist
- Presence of an aortopulmonary collateral that is expected to require unifocalization
- Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)
- Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
- Currently participating in an investigational drug study or another device study that would confound the study results
- Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure
- Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)
- 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...
- 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...
- 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
- Contraindications to peri-procedural anticoagulation
- Known to be non-responsive to aspirin or other antiplatelet therapies
- Known hypersensitivity or allergy to Nickel
- Known hypersensitivity to contrast media that cannot be adequately pre-medicated
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 minute to 6 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Stanford, California, United States; Aurora, Colorado, United States; Boston, Massachusetts, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.