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

NCT05268094 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Pediatric Heart Network

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • Christopher Petit, MD · Columbia University

  • Andrew Glatz, MD · Washington University School of Medicine

  • Sara Pasquali, MD · University of Michigan

  • Jenna Romano, MD · University of Michigan

  • Jeffrey Zampi, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-02
Primary Completion
2027-09-01
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268094 on ClinicalTrials.gov