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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT04467671
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tissue Engineered Vascular Grafts — COMBINATION_PRODUCT
    Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)

Study Details

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

Key Dates

Start date
Jul 15, 2020
Status verified
Jun 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tissue Engineered Vascular Grafts

Primary Outcome Measure

Safety and Tolerability of TEVG [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Samantha Fichtner, BSN, RN
[email protected]
614-355-5764
Victoria Shay
[email protected]
Mark Galantowicz, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
Nationwide Children's Hospital· Columbus, OH

Related Studies