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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

Not specified - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

24 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Patients will be eligible for inclusion in the study if they meet all of the following criteria.

1. Patient must be a candidate to undergo an extracardiac total cavopulmonary connection.
2. Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.

Exclusion Criteria:

• Patients will be excluded from participation in the study if they meet any of the following criteria.

1. Patient has an urgent/emergent operative status.
2. Patient has acute renal failure or renal insufficiency in the opinion of the investigator
3. Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
4. Patient has a pacemaker.
5. Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)
6. Patient has abnormal venous drainage (interrupted inferior vena cava \[IVC\]).
7. Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.
8. Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.
9. Patients taking any medications that in the opinion of the Investigator could interfere with the TEVG, including bisphosphonates (i.e. Clodronate or Zoledronate).
10. Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.
11. Preoperative hemoglobin \<11.0 mg/dL at time of patient's pre-admission testing.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Nationwide Children's Hospital

Study start

Jul 15, 2020 Actual

Primary completion

2029-12 Estimated

Study completion

2031-12 Estimated

First posted

Jul 13, 2020 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts