Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement (ARVA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01293188|
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : March 9, 2015
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.
|Condition or disease|
|Aortic Valve Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||434 participants|
|Official Title:||Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
|Biopresthetic aortic valve replacement.|
- Mortality [ Time Frame: 6 months ]
- Hemorragic and thrombo-embolitic complications [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293188
|Paris, France, 75018|
|Principal Investigator:||Bernard Iung||Assistance Publique - Hôpitaux de Paris|