Cardiovascular Abnormalities, Cardiovascular Diseases, DILV - Double Inlet Left Ventricle, DORV, Heart Defects, Congenital, Heart Diseases, HLH - Hypoplastic Left Heart Syndrome, Mitral Atresia, Single-ventricle, Tricuspid Atresia, Unbalanced AV Canal
Conditions
Keywords
Fontan, TEVG, Tissue Engineered Vascular Graft
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.
Detailed description
This investigation is a prospective, open-labeled clinical trial determining the safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Patients will be monitored for adverse events (AE) and serious adverse events (SAE). Special attention will be paid to the incidence of stenosis. We will determine graft-related morbidity and mortality for the second generation TEVGs which will include any post-operative complication such as any aneurismal dilation, stenosis, thromboembolic or infectious event that requires treatment and is thought to be caused by the graft as determined by the investigators and confirmed by the data safety monitoring board. The graft related complication rates will be compared between the first and second generation TEVGs. An interim analysis will be performed to assess the incidence of early (\<6 month) graft-related complications in the first 6 enrolled patients. Safety and tolerability will be assessed through serial imaging, to determine the effect of growth and remodeling on graft performance through echocardiography and 4-dimensional MRI. All appropriate patients requiring EC TCPC who meet study inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. All enrolled subjects will be required to have follow-up visits at Nationwide Children's Hospital for a minimum of 2 years following implant. After obtaining informed consent for the patient's parents, patients with single ventricle cardiac anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and monitoring will follow an established, standardized, clinical algorithm in which the patient's clinical status including complications and measurements of graft function will be serially evaluated and recorded over a two year period using physical examination, echocardiography, and MRI.
Interventions
COMBINATION_PRODUCTTissue Engineered Vascular Grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Gunze Limited
National Institutes of Health (NIH)
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of TEVG | 2 years | Assessed through graft related complications as determined by serial echocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of TEVG | 2 years | Evaluate graft performance based on MRI |
Countries
United States
Contacts
Primary ContactSamantha Fichtner, BSN, RN
Backup ContactVictoria Shay
Outcome results
None listed