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NCT05372757 · ClinicalTrials.gov registry record · NA
Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05372757: Completed NA study, sponsored by Medical University of South Carolina.
NCT05372757 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05372757, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
The long-term goal of this research initiative is to develop a new valve replacement option for neonates, infants and young children. The central hypothesis is that transplantation of a freshly isolated heart valve will be associated with superior outcomes compared to currently available options, including preserved cadaver valves, bioprosthetic tissue valves, or mechanical valves. This new operation has been named "partial heart transplantation". The proposed study is a single-center, nonrandomized single arm pilot trial of "partial heart transplantation" in neonates, infants and young children who require semilunar heart valve replacement. This "first in man" trial seeks to determine whether valve replacement using partial heart transplant is feasible and safe. Primary aims are survival one year and five years following the procedure. The hypothesis is that, when compared to historical controls who have undergone homograft valve replacement, those undergoing partial heart transplantation will have equal or superior survival one year and five years following the procedure. Secondary aims are to assess growth and function of the transplanted valve. The hypothesis is that when compared to historical controls who have undergone conventional valve replacement, those undergoing partial heart transplantation will have valve growth that corresponds with somatic growth and superior valve function 1 year following the procedure. Up to five patients will be enrolled in this trial over three years.
Primary Outcome
This is how feasibility will be measured. This will be answered as "yes" or "no".
Interventions
- PROCEDURE Partial Heart Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-05-03 |
| Est. Completion | 2023-11-30 |
| Phase | NA |
What the finished NCT05372757 record still lists
NCT05372757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Partial Heart Transplantation is the first listed.
NCT05372757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05372757 about?
NCT05372757 is a clinical study titled "Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction". The long-term goal of this research initiative is to develop a new valve replacement option for neonates, infants and young children. The central hypothesis is that transplantation of a freshly isolated heart valve will be associated with superior outcomes compared to currently available options, in...
What is the current status of trial NCT05372757?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2023-05-03. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT05372757?
The interventions under investigation include: Partial Heart Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT05372757?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05372757's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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