Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02186691
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2014-06-04
Brief Title:
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Status:
COMPLETED
Status Verified Date:
2023-04
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:
Long term survival of patients with repaired tetralogy of Fallot is excellent about 85 at 35 year-old However these patients are exposed to residual pulmonary stenosis PS andor pulmonary regurgitation PR It is well established that these lesions can lead to irreversible sequelae such as right ventricle dilatation and dysfunction Pulmonary valve replacement technique was developed to avoid long term right ventricular dysfunction Pulmonary valve replacement indications are based upon the presence of symptoms at exercise andor morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatationdysfunction The best timing of such intervention is still underdebate with the main aim of having the right balance between avoiding long term sequelae of PR or PS and being the latter possible to push ahead the need for new intervention Recent publication showed that myocardial diffuse fibrosis can contribute to irreversible alteration of myocardial contractility Quantification of diffuse fibrosis by magnetic resonance imaging is feasible and could help the physician to best determine the right timing for PVR in this population of patients Cardiac function assessment at rest and during exercise is possible using MR and our centre has developed a program for cardiac exercise during MRI This could help to detect infra clinic abnormality and to analyse myocardial adaptation during exercise
Detailed Description:
None
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