NCT04467671 Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
| NCT ID | NCT04467671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nationwide Children's Hospital |
| Condition | HLH - Hypoplastic Left Heart Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2020-07-15 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2020-07-15 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
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.
Contact & Investigator
Christopher Breuer, MD
STUDY CHAIR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT04467671 clinical trial?
This trial is open to participants of all sexes, studying HLH - Hypoplastic Left Heart Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04467671 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04467671 currently recruiting?
Yes, NCT04467671 is actively recruiting participants. Contact the research team at samantha.fichtner@nationwidechildrens.org for enrollment information.
Where is the NCT04467671 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT04467671 clinical trial?
NCT04467671 is sponsored by Nationwide Children's Hospital. The principal investigator is Christopher Breuer, MD at Nationwide Children's Hospital. The trial plans to enroll 24 participants.