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

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.