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Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement

NCT01293188 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 434

Last updated 2019-08-14

No results posted yet for this study

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.

Conditions

  • Aortic Valve Disease

Sponsors & Collaborators

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Bernard Iung · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01293188 on ClinicalTrials.gov