Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement (AOMYOC)

Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement
• Intervention / Treatment: Procedure: stenosis aortic valve

• Study Type: Observational
• Enrollment (Actual): 277

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with tight aortic stenosis with an indication of surgical treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Echocardiography	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
MRI Fibrosis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): January 11, 2019
• Study Completion (Actual): January 11, 2019

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 35RC12_8974 AOMYOC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No