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NCT05268094 · ClinicalTrials.gov registry record · NA
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
A NA study of Congenital Heart Disease in Children, sponsored by Carelon Research.
- Active
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05268094: Active NA study of Congenital Heart Disease in Children, sponsored by Carelon Research.
NCT05268094 is a NA study of Congenital Heart Disease in Children that is active but no longer recruiting, run by Carelon Research. The registered enrollment target is 300 participants, below the 1,968-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05268094, a NA study of Congenital Heart Disease in Children, is active but no longer recruiting, sponsored by Carelon Research.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Ductal Arterial Stent
- PROCEDURE Systemic-to-Pulmonary Artery Shunt
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- UCSF Benioff Children's Hospitals - Oakland
- Stanford Children's Health - Palo Alto
Pennsylvania
- Children's Hospital of Philadelphia - Philadephia
- University of Pittsburgh Medical Center - Pittsburgh
Alabama
- University of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Joe DiMaggio Children's Hospital - Hollywood
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2028-02-29 |
| Phase | NA |
What the registry record for NCT05268094 still lists
NCT05268094 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,968-participant average among 6 other Congenital Heart Disease in Children trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Congenital Heart Disease in Children appearing as the primary indexed condition, and to 2 interventions - of which Ductal Arterial Stent is the first listed.
NCT05268094 names 20 study sites across 17 states, led by California, Pennsylvania, Alabama.
Frequently Asked Questions
What is clinical trial NCT05268094 about?
NCT05268094 is a clinical study titled "Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)". 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 ventri...
What is the current status of trial NCT05268094?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-06-02. Estimated completion is 2028-02-29.
What conditions does trial NCT05268094 study?
This clinical trial studies the following conditions: Congenital Heart Disease in Children.
What interventions are being tested in trial NCT05268094?
The interventions under investigation include: Ductal Arterial Stent (DEVICE), Systemic-to-Pulmonary Artery Shunt (PROCEDURE).
Who is sponsoring clinical trial NCT05268094?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05268094 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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