CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 434 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01293188
NCT01293188N/ACompleted

Observatory of Anticoagulation After Bioprosthetic Aortic Valve Replacement

French Cardiology Society·observational·Posted Feb 10, 2011·Updated Aug 14, 2019

In Brief

An observational study for Aortic Valve Disease. Completed, enrolled 434 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2011
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.4 years ago