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. Identifier: NCT01293188
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : March 9, 2015
Information provided by (Responsible Party):
Bernard IUNG, French Cardiology Society

Brief Summary:

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

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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.

Primary Outcome Measures :
  1. Mortality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Hemorragic and thrombo-embolitic complications [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with calcified aortic stenosis operated on for bioprosthetic aortic valve replacement

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01293188

Bichat Hospital
Paris, France, 75018
Sponsors and Collaborators
French Cardiology Society
Principal Investigator: Bernard Iung Assistance Publique - Hôpitaux de Paris

Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP, Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O'Gara PT, O'Rourke RA, Otto CM, Shah PM, Shanewise JS; 2006 Writing Committee Members; American College of Cardiology/American Heart Association Task Force. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008 Oct 7;118(15):e523-661. doi: 10.1161/CIRCULATIONAHA.108.190748. Epub 2008 Sep 26.

Responsible Party: Bernard IUNG, Professor, French Cardiology Society Identifier: NCT01293188     History of Changes
Other Study ID Numbers: 10185
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: March 2015

Keywords provided by Bernard IUNG, French Cardiology Society:
Aortic Valve Replacement