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Tissue Engineering

Tissue Engineered Vascular Grafts for Heart Disease (TEVG-2 Trial)

Phase 2
Recruiting
Led By Mark Galantowicz, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
Must not have
Patient has abnormal venous drainage (interrupted inferior vena cava [IVC]).
Patient has an urgent/emergent operative status.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new type of surgery for people with heart problems. The new surgery is called "extracardiac total cavopulmonary connection." This trial is testing to see if the new surgery is safe and if it works well.

Who is the study for?
This trial is for children with certain heart defects who need a special surgery called extracardiac total cavopulmonary connection. They must be able to follow the study plan and not have urgent medical issues, pacemakers, severe heart valve problems, other serious health conditions, or need graft sizes outside of 12-24 mm. Kids with high lung blood pressure or abnormal veins can't join.
What is being tested?
The study tests second-generation tissue engineered vascular grafts (TEVG) in kids needing heart surgery to connect large veins to their lungs. It's checking if these new grafts are safe and work well over two years without using different treatment groups.
What are the potential side effects?
While specific side effects aren't listed here, TEVGs could potentially cause complications like infection, improper healing at the site where they're placed, clotting inside the graft, or an immune reaction against the graft material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for a specific heart surgery to improve blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My veins that return blood to my heart are not normal.
Select...
I need surgery urgently or as an emergency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability of TEVG
Secondary study objectives
Efficacy of TEVG

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tissue Engineered Vascular GraftsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tissue Engineered Vascular Grafts
2009
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,227,786 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,094 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,795,207 Total Patients Enrolled
Gunze LimitedOTHER
2 Previous Clinical Trials
4 Total Patients Enrolled
Mark Galantowicz, MDPrincipal InvestigatorNationwide Children's Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled
Christopher Breuer, MDStudy ChairNationwide Children's Hospital
Toshiharu Shinoka, MD/PhDStudy ChairNationwide Children's Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled

Media Library

Second-Generation Tissue Engineered Vascular Grafts (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT04467671 — Phase 2
Heart disease Research Study Groups: Tissue Engineered Vascular Grafts
Heart disease Clinical Trial 2023: Second-Generation Tissue Engineered Vascular Grafts Highlights & Side Effects. Trial Name: NCT04467671 — Phase 2
Second-Generation Tissue Engineered Vascular Grafts (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04467671 — Phase 2
~3 spots leftby Aug 2025
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