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

NCT05268094 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PHNCOMPASS
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 24

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.

Conditions

Congenital Heart Disease in Children

Keywords

Congenital Heart Disease; Ductal Dependent Pulmonary Blood Flow; Ductal Artery Shunt; Systemic-to-Pulmonary Artery Shunt

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Global Rank Score

  1 year

• Freedom from Adverse Events

  1 year

• Days Alive out of Hospital

  1 year

Study Arms (2)

Ductal Artery Stent

EXPERIMENTAL

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.

Device: Ductal Arterial Stent

Systemic-to-Pulmonary Artery Shunt

EXPERIMENTAL

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.

Procedure: Systemic-to-Pulmonary Artery Shunt

Interventions

Ductal Arterial Stent DEVICE

Drug-eluting ductal arterial stents will be placed by transcatheter method.

Also known as: Medtronic Resolute Onyx, Boston Scientific Promus Elite/Premier, Boston Scientific Synergy, Cordis Elunir, Abbott Xience

Ductal Artery Stent

Systemic-to-Pulmonary Artery Shunt PROCEDURE

A surgical connection will be made between a systemic artery and the pulmonary artery.

Systemic-to-Pulmonary Artery Shunt

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.).
• \. Pulmonary Atresia with Intact Ventricular Septum (PA/IVS) where Right Ventricle (RV) decompression is planned.
• \. Presence of MAPCAs: defined as an aortopulmonary collateral that is expected to require unifocalization.
• \. Non-confluent Pulmonary Arteries (i.e., isolated Pulmonary Artery (PA) of ductal origin).
• \. Acutely jeopardized branch Pulmonary Arteries (\>75% narrowing of proximal PA based on screening cross sectional imaging \[Computed Tomography Angiography (CTA) or cardiovascular Magnetic Resonance (cMR)\]).
• \. 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.
• \. 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.
• \. Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.).
• \. 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).
• \. Patient who does not plan to return to the enrolling center or another participating center for Glenn/CSR.

Sponsors & Collaborators

• Carelon Research: lead
• Pediatric Heart Network: collaborator

Study Sites (24)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

UCSF Benioff Children's Hospitals

Oakland, California, 94609, United States

Location

Stanford Children's Health

Palo Alto, California, 94304, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Levine Children's Hospital

Charlotte, North Carolina, 28203, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadephia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Children's Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

• Reddy D, Kleinloog R, Kinsley R. Pulmonary Atresia, Ventricular Septal Defect, and Major Aortopulmonary Collateral Arteries: The Natural History and Late Presentation. World J Pediatr Congenit Heart Surg. 2025 Mar;16(2):203-207. doi: 10.1177/21501351241311882. Epub 2025 Feb 4.

  PMID: 39905870 DERIVED

• Petit CJ, Romano JC, Zampi JD, Pasquali SK, McCracken CE, Chanani NK, Les AS, Burns KM, Crosby-Thompson A, Stylianou M, Kato B, Glatz AC; Pediatric Heart Network Investigators. Rationale and design of the randomized COmparison of Methods for Pulmonary blood flow Augmentation: Shunt versus Stent (COMPASS) trial: A Pediatric Heart Network study. Catheter Cardiovasc Interv. 2024 Oct;104(4):637-647. doi: 10.1002/ccd.31109. Epub 2024 Sep 23.

  PMID: 39311092 DERIVED

• Petit CJ, Romano JC, Zampi JD, Pasquali SK, McCracken CE, Chanani NK, Les AS, Burns KM, Crosby-Thompson A, Stylianou M, Kato B, Glatz AC; Pediatric Heart Network Investigators. Rationale and Design of the Randomized COmparison of Methods for Pulmonary Blood Flow Augmentation: Shunt Versus Stent (COMPASS) Trial: A Pediatric Heart Network Study. World J Pediatr Congenit Heart Surg. 2024 Nov;15(6):693-702. doi: 10.1177/21501351241266110. Epub 2024 Sep 23.

  PMID: 39308140 DERIVED

Related Links

• Pediatric Heart Network Current Studies

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christopher Petit, MD

  Columbia University

  STUDY CHAIR

• Andrew Glatz, MD

  Washington University School of Medicine

  STUDY CHAIR

• Sara Pasquali, MD

  University of Michigan

  STUDY CHAIR

• Jenna Romano, MD

  University of Michigan

  STUDY CHAIR

• Jeffrey Zampi, MD

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study staff and participants' families will be aware of treatment group due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive either an SPS or DAS. Overall randomization will be 1:1 to each treatment arm, with block randomization will be performed by center and by single vs. two ventricle status

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: March 7, 2022
• Study Start: June 2, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Protocol and Informed Consent Form will be shared within 12 months of publication of study results. Public Use Dataset will be made available after publication, timeframe to be decided.
• Access Criteria: Protocol and Informed Consent Form will be made available with results on clinicaltrials.gov. Public Use Dataset will be available on the Pediatric Heart Network public website and may be used in accordance with Pediatric Heart Network governance.

Locations

US (23); CA (1)