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Congenital Heart Disease in ChildrenCOMPASSNCT05268094

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

A study testing Ductal Arterial Stent and Systemic-to-Pulmonary Artery Shunt in people with Congenital Heart Disease in Children, run by Carelon Research at 24 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 day to 30 days
Conditions the study is for
Congenital Heart Disease in Children
What is being tested?
Ductal Arterial Stent and Systemic-to-Pulmonary Artery Shunt
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
24 sitesin 2 countries
Study dates
2 Jun 2022to 29 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 30 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

24 sites in 2 countries.

24 sites in 2 countries

United States23 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045

  • University of Alabama

    Birmingham, Alabama, 35233

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Levine Children's Hospital

    Charlotte, North Carolina, 28203

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38105

  • New York Presbyterian Hospital/Columbia University Irving Medical Center

    New York, New York, 10032

  • UCSF Benioff Children's Hospitals

    Oakland, California, 94609

  • Stanford Children's Health

    Palo Alto, California, 94304

  • Children's Hospital of Philadelphia

    Philadephia, Pennsylvania, 19104

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Children's Wisconsin

    Wauwatosa, Wisconsin, 53226

Other trials in United States

Canada1 site

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Ductal Arterial Stent, Systemic-to-Pulmonary Artery Shunt
Keywords
Congenital Heart Disease, Ductal Dependent Pulmonary Blood Flow, Ductal Artery Shunt, Systemic-to-Pulmonary Artery Shunt
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ductal Arterial StentDevice

    Also called Medtronic Resolute Onyx, Boston Scientific Promus Elite/Premier, Boston Scientific Synergy, Cordis Elunir

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

  • Systemic-to-Pulmonary Artery ShuntProcedure or surgery

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

Study groups in NCT05268094
Study groupRoleWhat they receive
Ductal Artery StentExperimentalTranscatheter ductal artery shunt will be placed by the interventional team. Drug-eluting coronary stent brand, length, and diameter are determined by the interventional team.
Receives: Device: Ductal Arterial Stent
Systemic-to-Pulmonary Artery ShuntExperimentalSurgical systemic-to-pulmonary artery shunt performed by the interventional team. SPS diameter, length, and material will be determined by the surgeon performing the intervention.
Receives: Procedure: Systemic-to-Pulmonary Artery Shunt

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (3)

  1. Global Rank Score

    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.

    Measured: 1 year

  2. Freedom from Adverse Events

    Safety, defined as freedom from procedural adverse events and complications, will be tracked and evaluated.

    Measured: 1 year

  3. Days Alive out of Hospital

    Days alive out of the hospital represents a patient-centered outcome, and functions as a composite endpoint.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2022
  2. Study start2 Jun 2022
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05268094
Sponsor's protocol ID
PHNCOMPASS
Acronym
COMPASS
Status last verified
Jan 2026
First submitted
19 Jan 2022
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All individual participant data collected by the Data Coordinating Center will be shared after posting of results and main study results publication.

Publications

  • 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.

    PubMed 39905870

  • 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.

    PubMed 39311092

  • 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.

    PubMed 39308140

Questions about this trial

What is this clinical trial studying?

A study testing Ductal Arterial Stent and Systemic-to-Pulmonary Artery Shunt in people with Congenital Heart Disease in Children, run by Carelon Research at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morbidity and/or Mortality Endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05268094, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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