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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05268094
Other study ID # PHNCOMPASS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2, 2022
Est. completion date September 1, 2026

Study information

Verified date February 2023
Source HealthCore-NERI
Contact Allison Crosby-Thompson
Phone 339-215-6593
Email allison.crosby-thompson@carelon.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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 information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
HealthCore-NERI Pediatric Heart Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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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