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Recruiting NCT03139786

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

Observational Aortic Valve, Bicuspid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Study the natural history of bicuspid.
Who it may be relevant to
Registry conditions: Aortic Valve, Bicuspid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Study the natural history of bicuspid
    Study the natural history of bicuspid

Primary outcome measures

  • Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid [Time frame: 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Identifiers

NCT: NCT03139786 · PI2012_843_0014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗