Aortic Valve Disease Clinical Trial
Official title:
Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement
The bioprosthetic aortic valve replacement is a frequent intervention because of the
predominance of calcified aortic stenosis, which is the most common valvular disease, and
aging of the population.
International guidelines recommend anticoagulant therapy during the 3 postoperative months,
but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the
low level of evidence available studies and their sometimes conflicting conclusions.
Questionnaires sent to practitioners have highlighted discrepancies between common practices
and recommendations.
However, there is no analysis of actual patterns of postoperative anticoagulation after
aortic valve replacement with bioprosthesis.
The aim of the ARVA observatory is to establish a cohort of 600 patients enrolled in 3 months
and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers French.
The study will include consecutive patients who agreed to participate in the study, which
meet the criteria for inclusion, that is to say consecutive patients operated on by a
bioprosthetic aortic valve replacement during the 3 months of inclusion. Patients will be
included immediately after completion of aortic valve replacement.
The data will be entered directly by the referent of each center, based on data from the
French Society of Cardiology accessible by Internet on a secure site.
The follow-up time will be 6 months
The incidence of thromboembolic complications and bleeding and mortality within 6 months will
be analyzed in a standardized manner according to the recommendations on the analysis of
morbidity and mortality after valve surgery.
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