Clinical trial
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.
Name
IDE18703
Description
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
Trial arms
Trial start
2020-07-15
Estimated PCD
2025-08-01
Trial end
2027-08-01
Status
Recruiting
Phase
Early phase I
Treatment
Tissue Engineered Vascular Grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)
Arms:
Tissue Engineered Vascular Grafts
Size
24
Primary endpoint
Safety and Tolerability of TEVG
2 years
Safety and Tolerability of TEVG
2 years
Safety and Tolerability of TEVG
2 years
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2024-05-06
1 organization
1 product
12 indications
Organization
Nationwide Children's HospitalIndication
Hypoplastic Left Heart SyndromeIndication
Double Inlet Left VentricleIndication
Mitral AtresiaIndication
Tricuspid AtresiaIndication
Atrioventricular septal defectIndication
Single-ventricleIndication
Congenital Heart DefectIndication
CongenitalIndication
Cardiovascular AbnormalitiesIndication
Cardiovascular DiseasesIndication
Heart Diseases