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Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement (ARVA)

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ClinicalTrials.gov Identifier: NCT01293188
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : March 9, 2015
Information provided by (Responsible Party):

February 9, 2011
February 10, 2011
March 9, 2015
January 2011
December 2013   (Final data collection date for primary outcome measure)
Mortality [ Time Frame: 6 months ]
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Complete list of historical versions of study NCT01293188 on ClinicalTrials.gov Archive Site
Hemorragic and thrombo-embolitic complications [ Time Frame: 6 months ]
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Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement
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.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with calcified aortic stenosis operated on for bioprosthetic aortic valve replacement
Aortic Valve Disease
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Biopresthetic aortic valve replacement.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2014
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years old
  • Patients operated on for single bioprosthetic aortic valve replacement during the study period:

    • with or without reinforcement
    • with or without associated CABG
    • with or without action on the ascending aorta
    • whether a first intervention or reoperation
  • Patients who agreed to participate in the study

Exclusion Criteria:

  • Replacement aortic valve homograft or autograft
  • Surgical procedures on another valve (conservative or prosthetic replacement)
  • Permanent Atrial Fibrillation
  • Processing anticoagulant vitamin K-long course
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Bernard IUNG, French Cardiology Society
French Cardiology Society
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Principal Investigator: Bernard Iung Assistance Publique - Hôpitaux de Paris
French Cardiology Society
March 2015