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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Tetralogy of Fallot With Pulmonary Stenosis

Treatments: Other: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02186691

2014-06

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• older than 14 year-old, with repaired tetralogy of Fallot requiring pulmonary valve

Exclusion criteria

• liver failure, kidney failure,
• contra indication to MRI study,
• non-affiliated to the national health care program

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

RV and LV ejection fraction assesment

Experimental group

Description:

assesment RV and LV ejection fraction after PVR measured by MRI

Treatment:

Other: MRI