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

NCT04467671 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-27

No results posted yet for this study

Summary

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Conditions

  • HLH - Hypoplastic Left Heart Syndrome
  • DORV
  • DILV - Double Inlet Left Ventricle
  • Mitral Atresia
  • Tricuspid Atresia
  • Unbalanced AV Canal
  • Single-ventricle
  • Heart Defects, Congenital
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
  • Heart Diseases

Interventions

COMBINATION_PRODUCT

Tissue Engineered Vascular Grafts

Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Gunze Limited

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Christopher Breuer, MD · Nationwide Children's Hospital

  • Toshiharu Shinoka, MD/PhD · Nationwide Children's Hospital

  • Mark Galantowicz, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04467671 on ClinicalTrials.gov