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

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease in Children

• 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.

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-07
• Study Start: 2022-06-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-09-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

  7. 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.

  8. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.).

  9. 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).

  10. Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

UCSF Benioff Children's Hospitals; 🇺🇸 Oakland, California, United States

Stanford Children's Health; 🇺🇸 Palo Alto, California, United States

Children's Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

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