Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia
Prospective Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia: Multicentre Study
1 other identifier
observational
232
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2010
CompletedFirst Submitted
Initial submission to the registry
April 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2035
June 15, 2026
June 1, 2026
24.6 years
April 10, 2017
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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