Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
- Conditions
- Congenital Heart Disease in Children
- Interventions
- Device: Ductal Arterial StentProcedure: Systemic-to-Pulmonary Artery Shunt
- Registration Number
- NCT05268094
- Lead Sponsor
- Carelon Research
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- Age ≤ 30 days at time of index procedure (DAS or SPS).
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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.).
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Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned.
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Presence of MAPCAs: defined as an aortopulmonary collateral that is expected to require unifocalization.
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Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin).
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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)]).
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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.
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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.
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Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.).
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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).
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Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ductal Artery Stent Ductal Arterial Stent Transcatheter ductal artery shunt will be placed by the interventional team. Drug-eluting coronary stent brand, length, and diameter are determined by the interventional team. Systemic-to-Pulmonary Artery Shunt Systemic-to-Pulmonary Artery Shunt Surgical systemic-to-pulmonary artery shunt performed by the interventional team. SPS diameter, length, and material will be determined by the surgeon performing the intervention.
- Primary Outcome Measures
Name Time Method Morbidity and/or Mortality Endpoint 1 year 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.
- Secondary Outcome Measures
Name Time Method Global Rank Score 1 year 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.
Freedom from Adverse Events 1 year Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.
Days Alive out of Hospital 1 year Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.
Trial Locations
- Locations (24)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
UCSF Benioff Children's Hospitals
🇺🇸Oakland, California, United States
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
🇺🇸New York, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Stanford Children's Health
🇺🇸Palo Alto, California, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Wisconsin
🇺🇸Wauwatosa, Wisconsin, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States