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Clinical Trials in Canada / NCT05268094
Active, not recruiting Not applicable

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

NCT05268094 · tracked via the Priya Life Science Canada tracker
Sponsor
Carelon Research
Phase
Not applicable
Started
2022-06-02
Last updated
2026-01-07

Condition(s) studied

Congenital Heart Disease in Children

Investigational drug(s) / intervention(s)

Ductal Arterial StentSystemic-to-Pulmonary Artery Shunt

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)

Trial sites (24)

FacilityCityRegionStatus
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 New York New York
Levine Children's Hospital Charlotte North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Children's Hospital of Philadelphia Philadephia Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Le Bonheur Children's Hospital Memphis Tennessee
UT Southwestern Medical Center Dallas Texas
Texas Children's Hospital Houston Texas
Primary Children's Hospital Salt Lake City Utah
Children's Wisconsin Wauwatosa Wisconsin
Hospital for Sick Children Toronto Ontario

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Official registry record

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.

View NCT05268094 on ClinicalTrials.gov ↗ ← All trials in Canada