Clinical Trials Directory

Trials / Completed

CompletedNCT02186691

Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot

Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
14 Years – 90 Years
Healthy volunteers
Not accepted

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) and/or 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 and/or morphological or functional parameters such as severe pulmonary regurgitation with right ventricle dilatation/dysfunction. 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.

Conditions

Interventions

TypeNameDescription
OTHERMRI

Timeline

Start date
2014-09-15
Primary completion
2019-10-18
Completion
2023-04-12
First posted
2014-07-10
Last updated
2023-04-14

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02186691. Inclusion in this directory is not an endorsement.