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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02186691
Enrollment
11
Registered
2014-07-10
Start date
2014-09-15
Completion date
2023-04-12
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetralogy of Fallot With Pulmonary Stenosis

Keywords

pulmonary valve replacement, tetralogy of Fallot

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.

Interventions

OTHERMRI

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
determination of the quantity of diffuse myocardial fibrosis2.5 yearsdetermine 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

MeasureTime frameDescription
determination of contractile reserve2.5 yearsdetermine if contractile reserve 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBeatrice BONELLO, MD

Assistance Publique Hopitaux De Marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026