Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement (ARVA)
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.
Aortic Valve Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement|
- Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Hemorragic and thrombo-embolitic complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Biopresthetic aortic valve replacement.|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293188
|Paris, France, 75018|
|Principal Investigator:||Bernard Iung||AP-HP|