NCT05268094

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Congenital Heart Disease in Children

Interventions

Type	Name	Description
DEVICE	Ductal Arterial Stent	Drug-eluting ductal arterial stents will be placed by transcatheter method.
PROCEDURE	Systemic-to-Pulmonary Artery Shunt	A surgical connection will be made between a systemic artery and the pulmonary artery.

Timeline

• Start date: 2022-06-02
• Primary completion: 2027-09-01
• Completion: 2028-02-29
• First posted: 2022-03-07
• Last updated: 2026-01-07

Locations

24 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study