Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055556
Status:
SUSPENDED
Last Update Posted:
2024-02-28
First Post:
2023-08-23
Brief Title:
Partial Heart Transplantation
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Partial Heart Transplantation for Severe Pediatric Semilunar Valve Dysfunction
Status:
SUSPENDED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment on hold per regulatory request for tissue verification process
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 replacementParticipants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None