Congenital Heart DiseaseNCT06055556
Partial Heart Transplantation
A study testing Partial Heart Transplantation and Freshly procured valve in people with Congenital Heart Disease, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Partial Heart Transplantation and Freshly procured valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Partial Heart Transplantation, Freshly procured valve
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Heart TransplantationProcedure or surgery
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".
Freshly procured valveOther
Fresh donor graft semilunar heart valve.
| Study group | Role | What they receive |
|---|---|---|
| Partial Heart Transplantation | Experimental | 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. Receives: Procedure: Partial Heart Transplantation; Other: Freshly procured valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible patients who can be matched for transplant and the tissues needed procured
A measure of feasibility.
Measured: Day 1
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.
Measured: Year 2
Secondary outcomes (2)
To determine whether valve replacement(s) using partial heart transplantation is safe.
This will be determined by survival and major complication rates.
Measured: Year 2
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.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start4 Aug 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: Study no longer needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Turek, MD, PhD, MBA, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055556
- Sponsor's protocol ID
- Pro00110600
- Status last verified
- May 2025
- First submitted
- 23 Aug 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
- ClinicalTrials.gov ID
- NCT06055556
- Acronym / sponsor ID
- Pro00110600
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study no longer needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Heart Transplantation | Experimental | Procedure: Partial Heart Transplantation, Other: Freshly procured valveParticipants 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. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Heart TransplantationPartial 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". | Procedure or surgery | Partial Heart Transplantation |
| Freshly procured valveFresh donor graft semilunar heart valve. | Other | Partial Heart Transplantation |
Primary outcome
Number of eligible patients who can be matched for transplant and the tissues needed procured
Time frame: Day 1
A measure of feasibility.
To assess valve growth following partial heart transplantation.
Time frame: Year 2
This will be determined by looking at valve growth compared to body growth over time based on post-operative imaging.
2 secondary outcomes
To determine whether valve replacement(s) using partial heart transplantation is safe.
Time frame: Year 2
To assess valve function following partial heart transplantation.
Time frame: Year 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Turek, MD, PhD, MBA principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Heart Transplantation and Freshly procured valve in people with Congenital Heart Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible patients who can be matched for transplant and the tissues needed procured (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.