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Clinical Trials/NCT02186691
NCT02186691
Completed
Not Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country11 target enrollmentSeptember 15, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tetralogy of Fallot With Pulmonary Stenosis
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
11
Locations
1
Primary Endpoint
determination of the quantity of diffuse myocardial fibrosis
Status
Completed
Last Updated
3 years ago

Overview

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) 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.

Registry
clinicaltrials.gov
Start Date
September 15, 2014
End Date
April 12, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

determination of the quantity of diffuse myocardial fibrosis

Time Frame: 2.5 years

determine if the quantity of diffuse myocardial fibrosis measured by cardiac magnetic resonnance (CMR) compare to baseline measure is correlated with decrease of RV volume and increase in RV and LV ejection fraction after PVR

Secondary Outcomes

  • determination of contractile reserve(2.5 years)

Study Sites (1)

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