Clinical trial NCT01293188: Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement
Official title: Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: Aortic Valve Replacement
Bioprosthetic
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with calcified aortic stenosis operated on for bioprosthetic aortic valve replacement

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Hemorragic and thrombo-embolitic complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bernard Iung
role: PRINCIPAL_INVESTIGATOR
References:
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