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Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement (ARVA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bernard IUNG, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01293188
First received: February 9, 2011
Last updated: September 27, 2013
Last verified: September 2013

February 9, 2011
September 27, 2013
January 2011
December 2013   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01293188 on ClinicalTrials.gov Archive Site
Hemorragic and thrombo-embolitic complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with calcified aortic stenosis operated on for bioprosthetic aortic valve replacement

Aortic Valve Disease
Not Provided
Biopresthetic aortic valve replacement.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
434
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01293188
10185
No
Bernard IUNG, French Cardiology Society
French Cardiology Society
Not Provided
Principal Investigator: Bernard Iung AP-HP
French Cardiology Society
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP