Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia

February 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Prospective Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia: Multicentre Study

The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • Recruiting
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with aortic bicuspidia examined in the echocardiography laboratory at one of the participating centers will be systematically eligible to participate in the study

Description

Inclusion Criteria:

  • All patients examined in the echocardiography laboratory whose objective examination was a bicuspid valve of the aortic valve
  • Bicuspidia may be formerly known

Exclusion Criteria:

  • Refusal to participate
  • Patients who had already undergone bicuspid surgery or ascending aorta before being examined at the echocardiography laboratory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid
Time Frame: 10 years
Analyzing the natural history of Bicuspidia
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2011

Primary Completion (ANTICIPATED)

July 1, 2025

Study Completion (ANTICIPATED)

July 1, 2025

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2012_843_0014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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