Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement

NCT ID: NCT03686527

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-11

Study Completion Date

2019-01-11

Brief Summary

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Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.

Detailed Description

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Conditions

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Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Echocardiography

stenosis aortic valve

Intervention Type PROCEDURE

The exams to be realized :

* a clinical examination with blood pressure
* a 12-lead surface electrocardiogram
* a standard biological assessment including NTproBNP (Brain Natriuretic Peptide)
* Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations)
* a cardiac MRI looking for fibrosis myocardial

MRI Fibrosis

stenosis aortic valve

Intervention Type PROCEDURE

The exams to be realized :

* a clinical examination with blood pressure
* a 12-lead surface electrocardiogram
* a standard biological assessment including NTproBNP (Brain Natriuretic Peptide)
* Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations)
* a cardiac MRI looking for fibrosis myocardial

Interventions

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stenosis aortic valve

The exams to be realized :

* a clinical examination with blood pressure
* a 12-lead surface electrocardiogram
* a standard biological assessment including NTproBNP (Brain Natriuretic Peptide)
* Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations)
* a cardiac MRI looking for fibrosis myocardial

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* major patient freely accepting to participate in the study
* non-opposition signed
* aortic surface \<1cm² or \<0.6cm² / m² of indication surgical restraint
* oriented to short interventional management surgical term
* LVEF Left ventricular ejection fraction\> 50%
* In the subgroup "MRI-fibrosis", absence of indication for performing MRI

Exclusion Criteria

* patient under guardianship, curatorship or safeguard of justice
* minor patient
* pregnant woman
* patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
* patient with severe coronary artery disease requiring revascularization
* allergy to the contrast product
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Rennes

Rennes, Brittany Region, France

Site Status

Countries

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France

Other Identifiers

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35RC12_8974 AOMYOC

Identifier Type: -

Identifier Source: org_study_id

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