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

April 12, 2023 updated by: HealthCore-NERI
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Not yet recruiting
        • Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Rajiv Chaturvedi, MD, PhD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama
        • Contact:
        • Principal Investigator:
          • Mark Law, MD
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Graziano, MD
    • California
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Children's Hospital Los Angeles
        • Contact:
      • Oakland, California, United States, 94609
        • Recruiting
        • UCSF Benioff Children's Hospitals
        • Contact:
        • Principal Investigator:
          • Jeffery Meadows, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Children's Health
        • Contact:
        • Principal Investigator:
          • Lynn Peng, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
        • Principal Investigator:
          • Tacy Downing, MD
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Guyon, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Dennis Kim, MD, PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
        • Contact:
          • Simran
        • Principal Investigator:
          • Nicola Maschietto, MD, PhD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Jeffrey Zampi, MD
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Glatz, MD. MSCE
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • New York Presbyterian Hospital/Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Christopher Petit, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Levine Children's Hospital
        • Principal Investigator:
          • Matthew Schwartz, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • David Winlaw, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Michael O'Byrne, MD, MSCE
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan Goldstein, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • John Costello, MD, MPH
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Not yet recruiting
        • Le Bonheur Children's Hospital
        • Contact:
        • Principal Investigator:
          • Shyam K Sathanandam, MD
    • Texas
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Athar Qureshi, MD
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Primary Children's Hospital
        • Contact:
        • Principal Investigator:
          • Dana Boucek, MD, MSCI
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Children's Wisconsin
        • Contact:
        • Principal Investigator:
          • Susan Foerster, MD

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.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ductal Artery Stent
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
Drug-eluting ductal arterial stents will be placed by transcatheter method.
Other Names:
  • Medtronic Resolute Onyx
  • Boston Scientific Promus Elite/Premier
  • Boston Scientific Synergy
  • Cordis Elunir
  • Abbott Xience
Experimental: Systemic-to-Pulmonary Artery Shunt
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
A surgical connection will be made between a systemic artery and the pulmonary artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity and/or Mortality Endpoint
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rank Score
Time Frame: 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.
1 year
Freedom from Adverse Events
Time Frame: 1 year
Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.
1 year
Days Alive out of Hospital
Time Frame: 1 year
Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Collaborators

Pediatric Heart Network

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

June 2, 2022

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHNCOMPASS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data collected by the Data Coordinating Center will be shared after posting of results and main study results publication.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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