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OpenTrials
Completed

NCT Number: NCT01293188

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bichat Hospital

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 6 months

Secondary outcomes

  1. Hemorragic and thrombo-embolitic complications

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: ARVA

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 10, 2011
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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