Brief Title
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement
Official Title
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
Brief Summary
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified. The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.
Study Type
Observational
Primary Outcome
Occurrence of clinical events according to left ventricular remodeling
Secondary Outcome
Evolution of left ventricular remodeling after aortic valvular replacement
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
440
Start Date
December 5, 2017
Completion Date
June 2025
Primary Completion Date
June 2025
Eligibility Criteria
Inclusion Criteria: - Aortic stenosis - Indication of Aortic Valve Replacement (Surgery or TAVI) Exclusion Criteria: - Rheumatismal or congenital aortic stenosis - Aortic insufficiency (grade >= 2/4) - Associated valvulopathy (grade >= 2/4) - Myocardial infarction antecedent - Severe renal failure - Cardiac surgery (Aorta abdominal) antecedent - Complex congenital cardiopathy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Helene Eltchaninoff, Pr, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03411304
Organization ID
2017/080/HP
Responsible Party
Sponsor
Study Sponsor
University Hospital, Rouen
Study Sponsor
Helene Eltchaninoff, Pr, Principal Investigator, Rouen University Hospital
Verification Date
September 2021