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

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

— AOMYOC  

Official title:

Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686527
• Other study ID #: 35RC12_8974 AOMYOC
• Status: Completed
• Start date: January 11, 2018
• Est. completion date: January 11, 2019

Study information

• Verified date: September 2018
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: January 11, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	CHU Rennes	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is a composite endpoint: all-cause death, cardiovascular hospitalization: cardiac decompensation, atrial fibrillation within 12 months of surgical or percutaneous aortic valve replacement.		1 day of inclusion