Cincinnati, OHNCT07114718Now EnrollingIRB Ready

Congenital Heart Disease Clinical Trial in Cincinnati, OH

Access cutting-edge congenital heart disease treatment through this clinical trial at a research site in Cincinnati. Study-provided care at no cost to qualified participants.

Sponsored by Starlight Cardiovascular Inc

Quick Self-Assessment

See if you qualify for this Cincinnati location

Preparing your pre-screening questions…

Expert Care in Cincinnati

Access congenital heart disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related congenital heart disease treatment provided free

Apply for This Cincinnati Location

Check if you qualify for this congenital heart disease clinical trial in Cincinnati, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cincinnati

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Cincinnati site if eligible
  4. 4Begin participation

About This Congenital Heart Disease Study in Cincinnati

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.

Sponsor: Starlight Cardiovascular Inc

Who Can Participate

Inclusion 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

Exclusion Criteria

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 stenting procedure
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 biventricular circulation
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cincinnati?

Yes, this clinical trial (NCT07114718) has an active research site in Cincinnati, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Congenital Heart Disease Treatment Options in Cincinnati, OH

If you're searching for congenital heart disease treatment options in Cincinnati, OH, this clinical trial (NCT07114718) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cincinnati research site is actively enrolling participants for this clinical trial. You'll receive care from experienced congenital heart disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all congenital heart disease clinical trials near you to find additional studies recruiting in your area.

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