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International Bicuspid Aortic Valve Consortium (BAVCon)
NCT01980797 · View on ClinicalTrials.gov ↗
Study Summary
Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in \>50% of BAV patients, and accounts for \~40% of the \>30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability. The Specific Aims of this study are: 1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease. 2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease. To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.
Conditions Studied
Study Locations (12)
Other
- Monaldi Hospital — Naples
- Second University of Naples — Naples
- University of Salerno — Salerno
- Hospital Vall d'Hebron — Barcelona
- University of Oxford — Oxford
Massachusetts
- Tufts Medical Center — Boston
- Boston Medical Center — Boston
Michigan
- University of Michigan — Ann Arbor
Minnesota
- Mayo Clinic — Rochester
Texas
- University of Texas Health Science Center at Houston — Houston
Quebec
- Laval University — Québec
Milan
- Istituto Policlinico San Donato — San Donato Milanese
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2013-11 |
| Est. Completion | 2028-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01980797
The ClinicalTrials.gov registry entry for NCT01980797 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 150 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Bicuspid Aortic Valve Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01980797 reports 12 study locations spanning 7 distinct geographic areas — top geographies include Other, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01980797 about?
NCT01980797 is a clinical study titled "International Bicuspid Aortic Valve Consortium (BAVCon)". Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. B...
What is the current status of trial NCT01980797?
This trial is currently active not recruiting. The enrollment target is 10,000 participants. The study started on 2013-11. Estimated completion is 2028-11.
What conditions does trial NCT01980797 study?
This clinical trial studies the following conditions: Bicuspid Aortic Valve Disease, Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01980797?
This trial is sponsored by Boston University, which has 150 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01980797 being conducted?
This trial has 12 study locations across Massachusetts, Michigan, Minnesota, Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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