Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268047
Status:
TERMINATED
Last Update Posted:
2011-07-06
First Post:
2005-12-20
Brief Title:
Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well In some studies an increase in pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month mortality after heart transplantation2 In this study the investigators would like to look at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure followed by heart transplantation
Detailed Description:
Children born with certain congenital heart diseases such as tricuspid atresia or single ventricle physiology normally undergo the Fontan procedure during their course of treatment The Fontan procedure however is palliative and some of these children will eventually require heart transplantation It has been shown in pre-clinical animal models that pulmonary vascular resistance actually increases after having the Fontan procedure however this has not been quantitated in the human population1
This is a retrospective chart review with the primary objective of examining Fontan patients with pulmonary vascular resistance and who have undergone heart transplantation We will review 50 charts at Childrens Healthcare of Atlanta Egleston Hospital Three other United States sites are participating All de-identified data will be forwarded to the Great Ormond Street Hospital in London England for study analysis In order to ascertain this objective the following data will be collected
1 Diagnosis
2 Surgical History
3 Information from Pre-transplant evaluation
4 Post-transplant hemodynamics
5 Post-transplant catheterization results
This is a retrospective chart review with the primary objective of examining Fontan patients with pulmonary vascular resistance and who have undergone heart transplantation We will review 50 charts at Childrens Healthcare of Atlanta Egleston Hospital Three other United States sites are participating All de-identified data will be forwarded to the Great Ormond Street Hospital in London England for study analysis In order to ascertain this objective the following data will be collected
1 Diagnosis
2 Surgical History
3 Information from Pre-transplant evaluation
4 Post-transplant hemodynamics
5 Post-transplant catheterization results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None