Congenital Heart Disease in Children Clinical Trial
— COMPASSOfficial title:
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 30 Days |
Eligibility | Inclusion Criteria: 1. 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. 2. Age = 30 days at time of index procedure (DAS or SPS). Exclusion Criteria: - 1. 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.). 2. Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned. 3. Presence of MAPCAs: defined as an aortopulmonary collateral that is expected to require unifocalization. 4. Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin). 5. 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)]). 6. 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. 8. 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. 11. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.). 12. 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). 13. Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR. |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Children's Hospital of Colorado | Aurora | Colorado |
United States | University of Alabama | Birmingham | Alabama |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Levine Children's Hospital | Charlotte | North Carolina |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | Joe DiMaggio Children's Hospital | Hollywood | Florida |
United States | Texas Children's Hospital | Houston | Texas |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Le Bonheur Children's Hospital | Memphis | Tennessee |
United States | New York Presbyterian Hospital/Columbia University Irving Medical Center | New York | New York |
United States | UCSF Benioff Children's Hospitals | Oakland | California |
United States | Stanford Children's Health | Palo Alto | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Children's Wisconsin | Wauwatosa | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
HealthCore-NERI | Pediatric Heart Network |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | Freedom from Adverse Events | Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated. | 1 year | |
Secondary | Days Alive out of Hospital | Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint. | 1 year |
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