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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

TEVG-2 Trial 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.Check my eligibility
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.See study design
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.

TEVG-2 Trial 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.

TEVG-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of TEVG
Secondary outcome measures
Efficacy of TEVG

TEVG-2 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
338 Previous Clinical Trials
5,220,122 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,413 Total Patients Enrolled
Gunze LimitedOTHER
2 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
Cardiovascular Abnormalities Research Study Groups: Tissue Engineered Vascular Grafts
Cardiovascular Abnormalities 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies for patients in this clinical trial?

"That is correct. The clinical trial described on clinicaltrials.gov appears to be actively recruiting patients at the moment. This specific study was posted on 7/15/2020, and updated as recently as 8/4/2022. They are hoping to enroll 24 total patients from 1 site."

Answered by AI

How many people are being given the chance to participate in this research?

"Yes, as of 8/4/2022 this trial is still recruiting patients that meet the requirements. Originally posted on 7/15/2020, the study needs 24 more participants from 1 site."

Answered by AI

Has the FDA cleared Tissue Engineered Vascular Grafts for use?

"Tissue Engineered Vascular Grafts have only been proven safe in Phase 2 trials, so they received a score of 2."

Answered by AI
Recent research and studies
~6 spots leftby Aug 2025