Evaluating a new type of vascular graft for heart surgery in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a single-arm, open-label investigation assessing the safety and efficacy of second-generation tissue engineered vascular grafts (TEVGs) used as conduits for extracardiac total cavopulmonary connection (EC TCPC) in pediatric patients. Participants will be monitored for adverse events and complications related to the graft, including stenosis and other post-operative issues. The study will involve serial imaging techniques, such as echocardiography and 4D MRI, to evaluate graft performance over a two-year follow-up period. An interim analysis will be conducted to assess early graft-related complications in the first six enrolled patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Mark Galantowicz, MD — Nationwide Children's Hospital
• Study coordinator: Samantha Fichtner, BSN, RN
• Email: samantha.fichtner@nationwidechildrens.org
• Phone: 614-355-5764

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.