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International Bicuspid Aortic Valve Consortium (BAVCon) (BAVCon)

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ClinicalTrials.gov Identifier: NCT01980797
Recruitment Status : Recruiting
First Posted : November 11, 2013
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Bicuspid Aortic Valve Disease Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve

  Show Detailed Description

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: International Bicuspid Aortic Valve Consortium (BAVCon)
Study Start Date : November 2013
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2033

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Bicuspid aortic valve disease

Group/Cohort Label - Bicuspid aortic valve

Group/Cohort Description -

  • Patients diagnosed with bicuspid aortic valve
  • All ages ≥8 years
  • Able to provide fully informed consent
Tricuspid aortic valve control patients

Group/Cohort Label - Tricuspid aortic valve control patients

Group/Cohort Description -Control patients will come from approximately matched patients without an identified bicuspid aortic valve who are trace, gender and geographically matched.

  • Patients not diagnosed with bicuspid aortic valve
  • All ages ≥8 years
  • Able to provide fully informed consent

Outcome Measures

Primary Outcome Measures :
  1. Bicuspid aortic valve disease [ Time Frame: 10 years ]
    The first specific aim is to identify the genetic causes of bicuspid aortic valve disease.

Secondary Outcome Measures :
  1. The development of thoracic aortic disease in patients with bicuspid aortic valve disease [ Time Frame: 10 years ]
    The second specific aim is to identify genetic and non-genetic factors to cause thoracic aortic disease in BAV patients.

Biospecimen Retention:   Samples With DNA
We are collecting DNA from either saliva or blood.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with and without bicuspid aortic valves disease

Inclusion Criteria:

  • Patients diagnosed as having a bicuspid aortic valve
  • All ages ≥8 years
  • Able to provide fully informed consent

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980797

Contact: Simon C Body, MD MPH 617-732-8127 sbody@partners.org

United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Gordon Huggins, MD    617-636-2807    ghuggins@tuftsmedicalcenter.org   
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Simon C Body, MD MPH    617-732-8127      
Contact: Michael Franke, MD MPH    617-732-8127    mfrancke@partners.org   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Anna Booher, MD    734-998-7955    amanion@med.umich.edu   
Contact: Mike Ranella    734-232-4128    ranellam@med.umich.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Hector Michelena, MD    507-284-3687    michelena.hector@mayo.edu   
Contact: Maurice Sarano, MD, FACC, FAHA    507-284-2904    sarano.maurice@mayo.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Josh Denny, MD, MS    615-936-1556    josh.denny@vanderbilt.edu   
Contact: Emilia McCann    615-936-1542    emilia.mccann@vanderbilt.edu   
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Siddharth Prakash, MD, PhD    713-500-7003    Siddharth.K.Prakash@uth.tmc.edu   
Contact: Truc Baccam, RN    713-500-6715    Truc.Baccam@uth.tmc.edu   
Canada, Quebec
Laval University Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Contact: Yohan Bossé, PhD    418-656-8711 ext 3725    yohan.bosse@criucpq.ulaval.ca   
Contact: Patrick Mathieu, MD, FRCSC    418-656-8711 ext 3173    patrick.mathieu@chg.ulaval.ca   
Istituto Policlinico San Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Alessandro Frigiola    39-0252774519    alessandro.frigiola@grupposandonato.it   
Contact: Francesca Pluchinotta, MD    39-0252774502    francesca.pluchinotta@grupposandonato.it   
Monaldi Hospital Recruiting
Naples, Italy, 80100
Contact: Giuseppe Limongelli, MD, PhD, FESC, FAHA    39-0817064050    limongelligiuseppe@libero.it   
Contact: Fiorella Fratta, MD    39 3384733322    fiorellafratta@hotmail.it   
Second University of Naples Recruiting
Naples, Italy, 80131
Contact: Alessandro Della Corte, MD, PhD    39 081 706 4020    aledellacorte@libero.it   
Contact: Ciro Bancone, MD, PhD    39 347 6268544    cirobancone@vodafone.it   
University of Salerno Recruiting
Salerno, Italy, 36-83023
Contact: Eduardo Bossone, MD, PhD    39-328-5415438    ebossone@hotmail.com   
Contact: Rodolfo Citro, MD, PhD    39 089 673377    rodolfocitro@gmail.com   
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Arturo Evangelista, MD       arturevangelistamasip@gmail.com   
United Kingdom
University of Oxford Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Malenka Bissell, MD, BM, MRCPCH    44 01865-221875    malenka.bissell@cardiov.ox.ac.uk   
Sponsors and Collaborators
Brigham and Women's Hospital
Study Chair: Simon C Body, MD MPH Brigham and Women's Hospital
More Information

Additional Information:
Responsible Party: Simon Body, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01980797     History of Changes
Other Study ID Numbers: 2013P000260
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Keywords provided by Simon Body, Brigham and Women's Hospital:
Bicuspid aortic valve disease
Thoracic aortic disease
Cardiac CT
Cardiac MRI

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Aortic Diseases
Aortic Valve Stenosis
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Vascular Diseases
Ventricular Outflow Obstruction