Identification of Genetic Causes of Calcific Aortic Valve Disease

Beth Israel Lahey Health

Status: Active, not recruiting

Conditions: Aortic Valve Cusp Abnormality; Calcific Aortic Stenosis - Bicuspid Valve; Calcific Aortic Stenosis; Aortic Valve Disease; Aortic Aneurysm; Aortic Valve Insufficiency; Aortic Valve Disease Mixed; Aortic Diseases; Aortic Valve Calcification

Treatments: Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.

Study type: Observational

Funder types: Other

Identifiers

NCT04149600

2018P000380

Details and patient eligibility

About

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery

Exclusion criteria

• Age < 20 years
• Unable/unwilling to consent
• History of aortic valve replacement or transcatheter aortic valve replacement (TAVR)
• History of endocarditis
• History of rheumatic fever
• History of chest radiotherapy
• History of organ transplant

Trial design

1,000 participants in 2 patient groups

Bicuspid aortic valve

Description:

We wish to investigate the etiology of calcific aortic valve disease, and aortic dilation or aneurysm in patients with a bicuspid aortic valve undergoing aortic valve replacement or aortic surgery.

Treatment:

Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.

Tricuspid aortic valve

Description:

Data and samples will be compared using a control group comprised of patients with a tricuspid aortic valve undergoing aortic surgery.

Treatment:

Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.