Identification of Genetic Causes of Calcific Aortic Valve Disease

NCT ID: NCT04149600

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-25

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bicuspid aortic valve

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.

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

Intervention Type PROCEDURE

Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

Tricuspid aortic valve

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

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

Intervention Type PROCEDURE

Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

Interventions

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

Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Simon Robson

Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2018P000380

Identifier Type: -

Identifier Source: org_study_id

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