Back to resultsPartial Heart Transplantation
Primary Purpose
Congenital Heart Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Partial Heart Transplantation
Freshly procured valve
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease
Eligibility Criteria
Inclusion Criteria: Congenital heart patient referred for a cardiac operation that involves valve replacement in pulmonary position Deemed acceptable for partial heart transplantation based on the standard evaluation process Exclusion Criteria: Contraindication for heart transplantation Severe bliateral long segment pulmonary arterial hypoplasia Bilateral pulmonary vein stenosis Persistent acidosis with a pH < 7.1 Failure to pass psychosocial evaluation Parental (custodial) alcohol and/or substance abuse Documented parental (custodial) child abuse or neglect Parent (custodian) with cognitive/psychiatric impairment severe enough to limit comprehension of medical regimen Infection disease exclusion criteria Evidence of active sepsis Hepatitis B surface antigenemia HIV positivity Pregnancy Financial hardship or insurance non-approval
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Partial Heart Transplantation
Arm Description
Participants will receive a partial heart transplantation to replace the pulmonary valve with fresh donor graft(s). This is an investigational procedure. This means this procedure is not done as a routine treatment for patients with congenital heart defects. Partial heart transplantation involves surgical replacement of the semilunar heart valve with the heart valve and supporting blood vessels and tissue from an organ donor. No other parts of the heart are transplanted besides the heart valve, blood vessel, and tissue surrounding the valve.
Outcomes
Primary Outcome Measures
Number of eligible patients who can be matched for transplant and the tissues needed procured
A measure of feasibility.
To assess valve growth following partial heart transplantation.
This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging.
Secondary Outcome Measures
To determine whether valve replacement(s) using partial heart transplantation is safe.
This will be determined by survival and major complication rates.
To assess valve function following partial heart transplantation.
This will be determined by looking for the development of valve stenosis over time based on post-operative imaging.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06055556
Brief Title
Partial Heart Transplantation
Official Title
Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The procedure, tests, medications, and follow-up visits will all be done per standard of care. Medical data will be collected to look at outcomes after surgery.
Detailed Description
The purpose of this study is to determine if a partial heart transplantation in patients with congenital heart disease is safe and feasible. Potential participants are patients 12 and younger with congenital heart defects in need of pulmonary valve replacement.Participants will have a partial heart transplant involving surgical replacement of the pulmonary valve with the heart valve and supporting blood vessels from an organ donor. The study procedure, tests, medications, and follow-up visits will all be done per standard of care for heart transplant patients. Data will be collected from chart review, before, during and after surgery and at standard of care follow-up visits. Study data will be compared to historical data of patients who have undergone other types of pulmonary valve replacement surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial Heart Transplantation
Arm Type
Experimental
Arm Description
Participants will receive a partial heart transplantation to replace the pulmonary valve with fresh donor graft(s). This is an investigational procedure. This means this procedure is not done as a routine treatment for patients with congenital heart defects. Partial heart transplantation involves surgical replacement of the semilunar heart valve with the heart valve and supporting blood vessels and tissue from an organ donor. No other parts of the heart are transplanted besides the heart valve, blood vessel, and tissue surrounding the valve.
Intervention Type
Procedure
Intervention Name(s)
Partial Heart Transplantation
Intervention Description
Partial heart transplantation involves surgical replacement of the semilunar heart valve with a fresh donor graft. The surgical procedure (homograft valve replacement) is common and standard of care. The investigational aspect of this is using a freshly procured valve rather than a cryopreserved, cadaveric one and also the use of limited immunosuppression to help maintain the freshly procured valve as "living tissue".
Intervention Type
Other
Intervention Name(s)
Freshly procured valve
Intervention Description
Fresh donor graft semilunar heart valve.
Primary Outcome Measure Information:
Title
Number of eligible patients who can be matched for transplant and the tissues needed procured
Description
A measure of feasibility.
Time Frame
Day 1
Title
To assess valve growth following partial heart transplantation.
Description
This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging.
Time Frame
Year 2
Secondary Outcome Measure Information:
Title
To determine whether valve replacement(s) using partial heart transplantation is safe.
Description
This will be determined by survival and major complication rates.
Time Frame
Year 2
Title
To assess valve function following partial heart transplantation.
Description
This will be determined by looking for the development of valve stenosis over time based on post-operative imaging.
Time Frame
Year 2
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Congenital heart patient referred for a cardiac operation that involves valve replacement in pulmonary position
Deemed acceptable for partial heart transplantation based on the standard evaluation process
Exclusion Criteria:
Contraindication for heart transplantation
Severe bliateral long segment pulmonary arterial hypoplasia
Bilateral pulmonary vein stenosis
Persistent acidosis with a pH < 7.1
Failure to pass psychosocial evaluation
Parental (custodial) alcohol and/or substance abuse
Documented parental (custodial) child abuse or neglect
Parent (custodian) with cognitive/psychiatric impairment severe enough to limit comprehension of medical regimen
Infection disease exclusion criteria
Evidence of active sepsis
Hepatitis B surface antigenemia
HIV positivity
Pregnancy
Financial hardship or insurance non-approval
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Turek, MD, PhD, MBA
Phone
919-681-2344
Email
joseph.turek@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Giangiacomo
Phone
919-684-3821
Email
dana.giangiacomo@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Turek, MD, PhD, MBA
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Partial Heart Transplantation
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