RECRUITING

Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

Conditions

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 Fontan TEVG Tissue Engineered Vascular Graft

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

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.

Quick Facts

Study Start:2020-07-15

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04467671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Samantha Fichtner, BSN, RN

CONTACT

614-355-5764

samantha.fichtner@nationwidechildrens.org

Joanne Chisolm, MSN, RN

CONTACT

joanne.chisolm@nationwidechildrens.org

Principal Investigator

Christopher Breuer, MD

STUDY_CHAIR

Nationwide Children's Hospital

Toshiharu Shinoka, MD/PhD

STUDY_CHAIR

Nationwide Children's Hospital

Mark Galantowicz, MD

PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Study Locations (Sites)

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

Christopher Breuer, MD, STUDY_CHAIR, Nationwide Children's Hospital
Toshiharu Shinoka, MD/PhD, STUDY_CHAIR, Nationwide Children's Hospital
Mark Galantowicz, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-15

Study Completion Date2027-08

Study Record Updates

Study Start Date2020-07-15

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Fontan
TEVG
Tissue Engineered Vascular Graft

Additional Relevant MeSH Terms

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