NCT03139786

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Sep 2010Apr 2035

Study Start

First participant enrolled

September 16, 2010

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2035

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

24.6 years

First QC Date

April 10, 2017

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analysis of 10 year mortality in cardiac surgery in a patient with bicuspid

    Analyzing the natural history of Bicuspidia

    10 years

Interventions

Study the natural history of bicuspid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Christophe TRIBOUILLOY, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

May 4, 2017

Study Start

September 16, 2010

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2035

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations