ACTIVE_NOT_RECRUITING

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

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Conditions

Congenital Heart Disease in ChildrenCongenital Heart DiseaseDuctal Dependent Pulmonary Blood FlowDuctal Artery ShuntSystemic-to-Pulmonary Artery Shunt

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-02
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05268094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 30 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Age ≤ 30 days at time of index procedure (DAS or SPS).
  1. * 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.).

Contacts and Locations

Principal Investigator

Christopher Petit, MD
STUDY_CHAIR
Columbia University
Andrew Glatz, MD
STUDY_CHAIR
Washington University School of Medicine
Sara Pasquali, MD
STUDY_CHAIR
University of Michigan
Jenna Romano, MD
STUDY_CHAIR
University of Michigan
Jeffrey Zampi, MD
STUDY_CHAIR
University of Michigan

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
UCSF Benioff Children's Hospitals
Oakland, California, 94609
United States
Stanford Children's Health
Palo Alto, California, 94304
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010
United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, 10032
United States
Levine Children's Hospital
Charlotte, North Carolina, 28203
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Children's Hospital of Philadelphia
Philadephia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
United States
UT Southwestern Medical Center
Dallas, Texas, 75235
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Children's Wisconsin
Wauwatosa, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Carelon Research

  • Christopher Petit, MD, STUDY_CHAIR, Columbia University
  • Andrew Glatz, MD, STUDY_CHAIR, Washington University School of Medicine
  • Sara Pasquali, MD, STUDY_CHAIR, University of Michigan
  • Jenna Romano, MD, STUDY_CHAIR, University of Michigan
  • Jeffrey Zampi, MD, STUDY_CHAIR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-02
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2022-06-02
Study Completion Date2027-04-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Congenital Heart Disease in Children