Ductal Arterial Stent: Drug-eluting ductal arterial stents will be placed by transcatheter method.
Systemic-to-Pulmonary Artery Shunt: A surgical connection will be made between a systemic artery and the pulmonary artery.
Study summary
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.
Eligibility
Sex
ALL
Min age
1 Day
Max age
30 Days
Healthy volunteers
No
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.
Primary outcome measure(s)
Morbidity and/or Mortality Endpoint — 1 year Rates of a composite major morbidity and/or mortality endpoint in the first year of life will be compared between neonates with ductal-dependent pulmonary blood flow randomized to receive either DAS or SPS as the initial palliation.
Trial sites (24)
Facility
City
Region
Status
University of Alabama
Birmingham
Alabama
Phoenix Children's Hospital
Phoenix
Arizona
Children's Hospital Los Angeles
Los Angeles
California
UCSF Benioff Children's Hospitals
Oakland
California
Stanford Children's Health
Palo Alto
California
Children's Hospital of Colorado
Aurora
Colorado
Children's National Medical Center
Washington D.C.
District of Columbia
Joe DiMaggio Children's Hospital
Hollywood
Florida
Children's Healthcare of Atlanta
Atlanta
Georgia
Boston Children's Hospital
Boston
Massachusetts
University of Michigan
Ann Arbor
Michigan
Washington University School of Medicine
St Louis
Missouri
New York Presbyterian Hospital/Columbia University Irving Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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