Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
NCT ID: NCT05268094
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
300 participants
INTERVENTIONAL
2022-06-02
2028-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predicting Pediatric Pulmonary Vein Stenosis Outcomes Using Data Acquired During a Cardiac Catheterization
NCT04696289
Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network
NCT00115934
Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
NCT03160742
A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
NCT01340378
Femoral Arterial Cannulation
NCT00486096
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Ductal Arterial Stent
Drug-eluting ductal arterial stents will be placed by transcatheter method.
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.
Systemic-to-Pulmonary Artery Shunt
A surgical connection will be made between a systemic artery and the pulmonary artery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ductal Arterial Stent
Drug-eluting ductal arterial stents will be placed by transcatheter method.
Systemic-to-Pulmonary Artery Shunt
A surgical connection will be made between a systemic artery and the pulmonary artery.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≤ 30 days at time of index procedure (DAS or SPS).
Exclusion Criteria
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.
1 Day
30 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pediatric Heart Network
OTHER
Carelon Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Petit, MD
Role: STUDY_CHAIR
Columbia University
Andrew Glatz, MD
Role: STUDY_CHAIR
Washington University School of Medicine
Sara Pasquali, MD
Role: STUDY_CHAIR
University of Michigan
Jenna Romano, MD
Role: STUDY_CHAIR
University of Michigan
Jeffrey Zampi, MD
Role: STUDY_CHAIR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
UCSF Benioff Children's Hospitals
Oakland, California, United States
Stanford Children's Health
Palo Alto, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadephia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Wisconsin
Wauwatosa, Wisconsin, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Pediatric Heart Network Current Studies
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHNCOMPASS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.