Shunt vs Stent for Congenital Heart Disease
(COMPASS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators or your doctor for guidance.
What data supports the effectiveness of the treatment Ductal Arterial Stent (DAS) for congenital heart disease?
Research shows that using a ductal stent (a small tube placed in the ductus arteriosus to keep it open) for congenital heart disease with duct-dependent pulmonary circulation can reduce the risk of death and complications compared to the Blalock-Taussig shunt. Additionally, patients with stents had better oxygen levels after the procedure.12345
Is the ductal stent or Blalock-Taussig shunt generally safe for humans?
How does the Ductal Arterial Stent treatment differ from other treatments for congenital heart disease?
The Ductal Arterial Stent (DAS) is a less invasive alternative to the Blalock-Taussig shunt for managing congenital heart disease with duct-dependent pulmonary circulation. It is associated with a lower risk of complications and mortality, and it improves oxygen levels more effectively than the surgical shunt.12389
What is the purpose of this trial?
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.
Research Team
Christopher Petit, MD
Principal Investigator
Columbia University
Andrew Glatz, MD
Principal Investigator
Washington University School of Medicine
Sara Pasquali, MD
Principal Investigator
University of Michigan
Jenna Romano, MD
Principal Investigator
University of Michigan
Jeffrey Zampi, MD
Principal Investigator
University of Michigan
Eligibility Criteria
The COMPASS trial is for newborns with certain heart defects needing a stable blood flow to the lungs. It's open to babies 30 days old or younger, without severe additional health issues, genetic anomalies that affect survival, or those requiring other major interventions alongside the tested procedures.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ductal Arterial Stent
- Systemic-to-Pulmonary Artery Shunt
Ductal Arterial Stent is already approved in United States, European Union for the following indications:
- Ductal-dependent pulmonary blood flow in neonates
- Ductal-dependent pulmonary blood flow in neonates
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carelon Research
Lead Sponsor
HealthCore-NERI
Lead Sponsor
Pediatric Heart Network
Collaborator