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Calculating Wall Shear Stress in Infant Pulmonary Veins

Study acronym: PVS-WSS
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Sep 2026 → Jun 2027
See other at-risk trials from Children's Hospital of Philadelphia

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 2026 to Jun 2027
    • Study completion pushed from Mar 2027 to Jun 2028
    • Eligibility criteria expanded, about 9 words
    v4
  2. Primary completion date: Sep 2025 to Sep 2026
    • Study completion date: Mar 2026 to Mar 2027
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Sep 30, 2024
    • Study site revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to better understand pediatric pulmonary vein stenosis (PVS), which is the narrowing of blood vessels that connect the lungs to the heart. PVS is a life-threatening disease without a clear cause. The investigators think patients who develop PVS have an increased Wall Shear Stress (WSS) level in the pulmonary veins, which is the force placed on the walls of the veins. This study will determine if WSS can be calculated in the pulmonary veins of infants using Ferumoxytol enhanced Cardiac Magnetic Resonance Imaging (FcMRI). If possible, the investigators aim to use FcMRI to better screen patients at risk of PVS and to help guide therapy in patients with PVS.
Trial Details
NCT Number NCT06440408
Lead Sponsor Children's Hospital of Philadelphia
Conditions
(from sponsor)		 Pulmonary Vein Stenosis
Related terms Stenosis, Pulmonary Vein
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov