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Comparing two methods to improve blood flow in newborns with heart defects

Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)

Not applicable Interventional Carelon Research · NCT05268094

This study is testing two different methods to improve blood flow in newborns with heart defects to see which one helps them do better in their first year of life.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages1 Day to 30 Days
SexAll
SponsorCarelon Research Academic / other
Locations24 sites (Birmingham, Alabama and 23 other locations)
Trial IDNCT05268094 on ClinicalTrials.gov

What this trial studies

The COMPASS trial is a multicenter randomized interventional trial aimed at evaluating the effectiveness of two methods for augmenting pulmonary blood flow in neonates with congenital heart disease. Participants will be randomly assigned to receive either a systemic-to-pulmonary artery shunt or a ductal artery stent, with the primary goal of comparing outcomes related to major morbidity and mortality within the first year of life. The study will follow participants closely to assess the failure rates of each intervention and their subsequent impact on patient outcomes. This trial addresses a significant gap in knowledge regarding the best initial palliative approach for these vulnerable patients.

Who should consider this trial

Good fit: Ideal candidates for this study are neonates with congenital heart disease and ductal-dependent pulmonary blood flow who are under 30 days old and for whom either a ductal artery stent or systemic-to-pulmonary artery shunt is deemed appropriate.

Not a fit: Patients who may not benefit from this study include those for whom alternative interventions are indicated, such as those requiring a right ventricle-pulmonary artery conduit or primary complete anatomic repair.

Why it matters

Potential benefit: If successful, this trial could provide critical insights into the most effective method for improving pulmonary blood flow in neonates with congenital heart disease, potentially leading to better survival rates and quality of life.

How similar studies have performed: While this approach has not been extensively tested in previous multicenter studies, it aims to fill a critical knowledge gap, suggesting that it is a novel investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Neonates with Congenital Heart Disease (CHD) and ductal-dependent pulmonary blood flow requiring only a stable source of pulmonary blood flow as the initial palliation, for whom the clinical decision is made at the enrolling center that this is best achieved by either DAS or SPS.
2. Age ≤ 30 days at time of index procedure (DAS or SPS).

Exclusion Criteria:

* 1. Any patient for whom the clinical decision at the enrolling center is that an initial intervention other than DAS or SPS is indicated (e.g., Right Ventricle-Pulmonary Artery (RV-PA) conduit, Right Ventricular Outflow Tract (RVOT) stent, primary complete anatomic repair, etc.).

  2. Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned.

  3. Presence of MAPCAs: defined as an aortopulmonary collateral that is expected to require unifocalization.

  4. Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin).

  5. Acutely jeopardized branch Pulmonary Arteries (\>75% narrowing of proximal PA based on screening cross sectional imaging \[Computed Tomography Angiography (CTA) or cardiovascular Magnetic Resonance (cMR)\]).

  6. Bilateral Patent Ductus Arteriosis (PDA). 7. Patient who, at the time of enrollment, is deemed not to be a candidate for eventual Glenn or Complete Surgical Repair (CSR) for any reason.

  8. Birth weight \<2.0 kg. 9. Gestational age \<34 weeks at birth. 10. Patient for whom additional intervention is expected concomitant with, or prior to, DAS or SPS (e.g., atrial septostomy, aortic arch intervention, or RV outflow tract intervention) - except for branch PA arterioplasty or stent/balloon angioplasty.

  11. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.).

  12. Specific known genetic anomaly which, in the opinion of the investigator, would be expected to significantly alter clinical course in the first year of life (e.g., Trisomy 13/18, CHARGE, VACTERL).

  13. Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR.

Where this trial is running

Birmingham, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Congenital Heart Disease in ChildrenCongenital Heart DiseaseDuctal Dependent Pulmonary Blood FlowDuctal Artery ShuntSystemic-to-Pulmonary Artery Shunt
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.