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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Drug-eluting ductal arterial stents will be placed by transcatheter method.
A surgical connection will be made between a systemic artery and the pulmonary artery.
University of Alabama
Birmingham, Alabama, United States
Morbidity and/or Mortality Endpoint
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.
Time frame: 1 year
Global Rank Score
All participants will be assigned a Global Rank Score, which is a rank based on a pre-specified hierarchical ranking of outcomes. This combines various endpoints into a single quantifiable endpoint with weighting of the severity of the component endpoints, and allows for the inclusion of endpoints of different forms. Global rank scores will range from 1-7.
Time frame: 1 year
Freedom from Adverse Events
Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.
Time frame: 1 year
Days Alive out of Hospital
Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.
Time frame: 1 year
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