Aortic Valve, BicuspidNCT03139786
Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia
An observational study of Aortic Valve, Bicuspid, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve, Bicuspid
- What is being tested?
- Study the natural history of bicuspid
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2010to Apr 2035
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients examined in the echocardiography laboratory whose objective examination was a bicuspid valve of the aortic valve
- Bicuspidia may be formerly known
Who cannot join
- Refusal to participate
- Patients who had already undergone bicuspid surgery or ascending aorta before being examined at the echocardiography laboratory
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Christophe TRIBOUILLOY, PhD, +33322455885, tribouilloy.christophe@chu-amiens.fr
About this study
Official title: 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.
- Conditions
- Aortic Valve, Bicuspid
- Being tested
- Study the natural history of bicuspid
- Medical subject headings
- Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study the natural history of bicuspidOther
Study the natural history of bicuspid
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid
Analyzing the natural history of Bicuspidia
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start16 Sep 2010
- Primary completionApr 2035 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve, BicuspidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139786
- Sponsor's protocol ID
- PI2012_843_0014
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No