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

Aortic Valve, Bicuspid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03139786
• Other study ID #: PI2012_843_0014
• Status: Recruiting
• Start date: October 14, 2011
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe TRIBOUILLOY, PhD
• Phone: +33322455885
• Email: tribouilloy.christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve, Bicuspid
• Bicuspid Aortic Valve Disease

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid	Analyzing the natural history of Bicuspidia	10 years