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Clinical Trial 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.


Clinical Trial Description

In neonates with ductal-dependent blood flow there remains valid uncertainty regarding the comparative benefits of ductal artery stent (DAS) with the traditional systemic-to-pulmonary artery shunt (SPS) palliation due to the lack of previous multicenter studies. COMPASS is a prospective multicenter randomized interventional trial where participants will be randomized to receive either an SPS or DAS to compare rates of a composite major morbidity/mortality endpoint in the first year of life. The study objectives are to perform an intention-to-treat analysis of participants' outcomes, and to describe the failure rate for neonatal candidates for DAS and the impact of this failure on the post-SPS course. Participants will be followed through the first year of life. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05268094
Study type Interventional
Source HealthCore-NERI
Contact Allison Crosby-Thompson
Phone 339-215-6593
Email allison.crosby-thompson@carelon.com
Status Recruiting
Phase N/A
Start date June 2, 2022
Completion date September 1, 2026

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