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Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

Study acronym: TEVG-2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 27, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Aug 2025 to Aug 2026
    • Site contact updated
    v7
  2. Site details revisedv6
  3. 3 versions Re-verified since Aug 16, 2021, no change to tracked fieldsv3-v5
  4. Primary endpoints revised (3)
    • Start date changed from estimate of Jul 1, 2020 to Jul 15, 2020
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
Trial Details
NCT Number NCT04467671
Lead Sponsor Nationwide Children's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Gunze Limited, National Institutes of Health (NIH)
Conditions
(from sponsor)		 HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia, Tricuspid Atresia, Unbalanced AV Canal, Single-ventricle, Heart Defects, Congenital +3 more
Related terms Cardiovascular Abnormalities, Cardiovascular Diseases, Heart Defects, Congenital, Heart Diseases, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Univentricular Heart
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov