Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT06055556
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.
Study:
NCT06055556
Study Brief:
Protocol Section:
NCT06055556