Clinical Trials Logo
  1. Home
  2. Bicuspid Aortic Valve
  3. NCT02899624
  4. Details
NCT02899624 Clinical Trial

Whole Exome Sequencing in Bicuspid Aortic Valve Patients

Bicuspid Aortic Valve Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02899624
Other study ID # 2013-09
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2016
Last updated September 9, 2016
Start date January 2014
Est. completion date January 2018

Study information
Verified date September 2016
Source Assistance Publique Hopitaux De Marseille
Contact Jean François Avierinos
Email jean-francois.avierinos@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three. It is conventionally associated with histological abnormalities of the wall of the ascending aorta, risk factors of aortic dystrophy observed in 50% of cases, and dissection. Long considered an accident of development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and aortic dystrophy suggests the existence of a genetic predisposition and a common genetic origin for these two pathologies.

Data on the genetic basis of the BAV are still limited, but the existence of a large phenotypic diversity suggests the involvement of other genes. The establishment of large collections of DNA will allow great advances in this field.

The purpose of this project is to confirm the existence of a genetic determinism at the origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying genetic defects associated with the presence of a BAV in a series of candidate genes.

Recruitment information / eligibility
Status Recruiting
Enrollment 427
Est. completion date January 2018
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography

- With or without an aneurysm of the ascending thoracic aorta nonsyndromic

Exclusion Criteria:

- aortic syndromic pathology

- antecedent of acute articular rhumatism

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Extra blood draw samples

• additional tissue samples

Locations
Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of genetic abnormalities 3 years No
See also
  Status Clinical Trial Phase
Recruiting NCT01390181 - The Effect of Losartan in Bicuspid Aortic Valve Patients N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Active, not recruiting NCT03635424 - Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study N/A
Recruiting NCT06153407 - Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Active, not recruiting NCT03474159 - Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve by Multimodal Imaging N/A
Not yet recruiting NCT06375590 - NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Recruiting NCT05739253 - Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Completed NCT01823432 - Genetic Risks for Bicuspid Aortic Valve Disease
Completed NCT02679261 - Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve Phase 3
Completed NCT01920815 - Bicuspid Valve Aortopathy Feasibility Study
Recruiting NCT04817735 - The CASPER Registry N/A
Recruiting NCT05708118 - Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
Recruiting NCT03495050 - BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Completed NCT01760668 - Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome N/A
Not yet recruiting NCT05711693 - Measurement of Heart-carotid Pulse Wave Velocity (hcPWV) by Laser Doppler Vibrometry (LDV) N/A
Completed NCT05836363 - Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
Completed NCT02283970 - Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)
Active, not recruiting NCT01026571 - Identification of Genetic Causes of Bicuspid Aortic Valve Disease
Completed NCT00412386 - Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve N/A
Recruiting NCT03440697 - Pathogenetic Basis of Aortopathy and Aortic Valve Disease