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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 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05372757
The ClinicalTrials.gov registry entry for NCT05372757 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Partial Heart Transplantation is the first listed.
NCT05372757 reports 0 study locations.
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.
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