Clinical Trial

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

Study acronym: COMPASS
Active, Not Recruiting
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2022-03-04; most recent amendment 2026-01-05.
Status change: Recruiting → Active, Not Recruiting 2025-12-09
Status change: Not Yet Recruiting → Recruiting 2022-06-02
Trial Details
NCT Number NCT05268094
Lead Sponsor Carelon Research
Collaborators: Pediatric Heart Network
Conditions Congenital Heart Disease in Children
Enrollment 300 participants
Start Date 2022-06-02
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-02-29 (estimated)
Updated on ClinicalTrials.gov 2026-01-07