International Bicuspid Aortic Valve Consortium (BAVCon)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-005324
    NCT ID: NCT01980797
    Sponsor Protocol Number: 2013P000260

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Adult patients ≥18 years old with bicuspid aortic valve diagnosed by echocardiogram.
  • Adult patients ≥18 years old without bicuspid aortic valve.
  • Able to provide fully informed consent.
  • For retrospective analysis/repository:
    • Patients who indicated Yes to MN Research Authorization.

Exclusion Criteria:

  • For retrospective analysis/repository:
    • Patients who indicated No to MN Research Authorization.

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hector Michelena, M.D.

Open for enrollment

Contact information:

Hector Michelena M.D.

(507)284-4317

Michelena.Hector@mayo.edu

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CLS-20302309

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