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Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts (TEVG-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467671
Recruitment Status : Recruiting
First Posted : July 13, 2020
Last Update Posted : August 5, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Gunze Limited
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
HLH - Hypoplastic Left Heart Syndrome DORV DILV - Double Inlet Left Ventricle Mitral Atresia Tricuspid Atresia Unbalanced AV Canal Single-ventricle Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Combination Product: Tissue Engineered Vascular Grafts Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2027


Arm Intervention/treatment
Experimental: Tissue Engineered Vascular Grafts Combination Product: Tissue Engineered Vascular Grafts
Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)




Primary Outcome Measures :
  1. Safety and Tolerability of TEVG [ Time Frame: 2 years ]
    Assessed through graft related complications as determined by serial echocardiogram

  2. Safety and Tolerability of TEVG [ Time Frame: 2 years ]
    Assessed through graft related complications as determined by serial MRI

  3. Safety and Tolerability of TEVG [ Time Frame: 2 years ]
    Assessed through adverse events


Secondary Outcome Measures :
  1. Efficacy of TEVG [ Time Frame: 2 years ]
    Evaluate graft performance based on MRI

  2. Efficacy of TEVG [ Time Frame: 2 years ]
    Measured graft volume(mL) as determined by MRI

  3. Efficacy of TEVG [ Time Frame: 2 years ]
    Measured graft length (mm) as determined by MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467671


Contacts
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Contact: Samantha Fichtner, BSN, RN 614-355-5764 samantha.fichtner@nationwidechildrens.org
Contact: Joanne Chisolm, MSN, RN joanne.chisolm@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43215
Contact: Samantha Fichtner, BSN, RN    614-355-5764    samantha.fichtner@nationwidechildrens.org   
Contact: Joanne Chisolm, MSN, RN       joanne.chisolm@nationwidechildrens.org   
Principal Investigator: Mark Galantowicz, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Gunze Limited
National Institutes of Health (NIH)
Investigators
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Study Chair: Christopher Breuer, MD Nationwide Children's Hospital
Study Chair: Toshiharu Shinoka, MD/PhD Nationwide Children's Hospital
Principal Investigator: Mark Galantowicz, MD Nationwide Children's Hospital
Publications:

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Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT04467671    
Other Study ID Numbers: IDE18703
1UG3HL148693 ( U.S. NIH Grant/Contract )
1UH3HL148693 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Biological Samples: We plan to make available representative samples of the bone marrow-derived mononuclear cells and seeded scaffold to a NIH-designated entity (RM Innovation Catalyst) for in depth and independent characterization. Specifically, for each TEVG manufactured, 1 ml of bone marrow-derived mononuclear cells and a 5mm x 5mm section of the seeded scaffold will be sampled, packed, and transported to the RM Innovation Catalyst per their instructions. In addition, copies of the batch record and completed certificate of analysis will be forwarded to the NIH-designated laboratory.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Prior to study initiation, the US FDA will have a comprehensive description of the processes followed to assure the accuracy, reliability, integrity, availability, and authenticity of required records and signatures supporting the data reported in the CSR will be provided to the Agency for confirmation that it will support a regulatory filing for TEVG. Every 6 months throughout the study, data will be shared with RM Innovation Catalyst, with a final locked data set no later than six months prior to the end of the award. Data from our long-term follow up policy will be made available on an annual basis if requested by the RM Innovation Catalyst or the NIH.
Access Criteria: De-identified data will be provided to RM Innovation Catalyst. A Clinical Study Report will be submitted to the US FDA following the International Conference on Harmonization E3 Guideline for Industry: Structure and Content of Clinical Study Reports. Summary results of the trial will be submitted to ClinicalTrial.gov within one year of the primary completion date (per regulation and NIH policy). Results of screening tests and subjects participation in the study and ongoing test results will be shared with their primary care physician and/or primary cardiologist if cardiac care is being provided outside of Nationwide Children's Hospital.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nationwide Children's Hospital:
Fontan
TEVG
Tissue Engineered Vascular Graft
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Univentricular Heart
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Cardiovascular Abnormalities
Tricuspid Atresia
Congenital Abnormalities
Heart Valve Diseases