RecruitingPhase 2

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

United States24 participantsStarted 2020-07-15

Plain-language summary

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

Who can participate

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Patient has an urgent/emergent operative status.
✕. Patient has acute renal failure or renal insufficiency in the opinion of the investigator
✕. Patient requires a graft less than 12 mm or greater than 24 mm in diameter.
✕. Patient has a pacemaker.
✕. Patient has pulmonary vascular resistance greater than 4 um2 (u=Wood's units)
✕. Patient has abnormal venous drainage (interrupted inferior vena cava \[IVC\]).
✕. Patient presents with significant atrio-ventricular valve regurgitation that in the opinion of the investigator, makes them ineligible.
✕. Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.

What they're measuring

Safety and Tolerability of TEVG

Timeframe: 2 years

Safety and Tolerability of TEVG

Timeframe: 2 years

Safety and Tolerability of TEVG

Timeframe: 2 years

Trial details

NCT IDNCT04467671

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Samantha Fichtner, BSN, RN

614-355-5764 samantha.fichtner@nationwidechildrens.org

View on ClinicalTrials.gov More HLH - Hypoplastic Left Heart Syndrome trials