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

Launched by CARELON RESEARCH · Mar 4, 2022

Keywords

ClinConnect Summary

The COMPASS Trial is a study looking at two different ways to improve blood flow to the lungs in newborns with a heart condition called congenital heart disease. These babies often need special treatment to ensure they get enough blood flow to their lungs, and this trial compares two methods: one involves placing a shunt (a small tube) to direct blood flow from the body to the lungs, while the other uses a stent (a small support device) to keep a blood vessel open. The goal is to see which method works better for these newborns.

To participate in this trial, babies must be 30 days old or younger and have a specific type of heart condition that requires either the shunt or stent as their first treatment option. Unfortunately, some babies will not qualify for the study, including those with certain other heart issues or serious health problems. For those who join, doctors will closely monitor their health for the first year of life to see how well each treatment works. This trial is currently recruiting participants, so families interested should talk to their healthcare provider for more information.

Gender

ALL

Eligibility 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.