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

Study acronym: COMPASS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Sep 1, 2026 to Sep 1, 2027
    • Study completion date: Apr 1, 2027 to Feb 29, 2028
    v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 24 of 24 sites
    v9
  3. Primary completion date: Mar 1, 2026 to Sep 1, 2026
    • Study completion date: Sep 1, 2026 to Apr 1, 2027
    v8
  4. Site details revised at 1 of 24 sitesv7
  5. Study sites: 22 to 24v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 23 to 22v5
  2. Re-verified, no change to tracked fieldsv4
  3. Study sites revised (23)v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 15, 2022 to Jun 2, 2022
    • Site details revised at 23 of 23 sites
    • Study title revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05268094
Lead Sponsor Carelon Research
Collaborators: Pediatric Heart Network
Conditions
(from sponsor)		 Congenital Heart Disease in Children
Related terms Heart Defects, Congenital
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov