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

Prospective, Open-labeled, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of the Second-generation Tissue Engineered Vascular Graft as Vascular Conduits for Extracardiac Total Cavopulmonary Connection.

This study is testing a new type of heart surgery graft for children to see if it is safe and works well for their needs.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sex: All
• Sponsor: Nationwide Children's Hospital (other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT04467671 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients who are candidates for an extracardiac total cavopulmonary connection and meet specific inclusion criteria.

Not a fit: Patients with urgent operative status, significant renal issues, or specific anatomical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for children with complex heart conditions requiring vascular grafts.

How similar studies have performed: While there have been studies on tissue engineered vascular grafts, this specific approach and its second-generation design are relatively novel.

Eligibility criteria

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 this trial is running

Columbus, Ohio

• 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

Conditions: HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia, Tricuspid Atresia, Unbalanced AV Canal, Single-ventricle, Heart Defects, Congenital