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NCT Number: NCT04149600

Identification of Genetic Causes of Calcific Aortic Valve Disease

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Calcific Aortic Stenosis Aneurysm Aortic Aneurysm Aortic Diseases Aortic Valve Calcification Aortic Valve Cusp Abnormality Aortic Valve Disease Aortic Valve Disease Mixed Aortic Valve Insufficiency Aortic Valve, Calcification of Calcific Aortic Stenosis - Bicuspid Valve Cardiovascular Diseases Heart Diseases Heart Valve Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Identification of expression signatures of aortic valve development and calcification in the macroscopically normal and abnormal portions of aortic valves excised during aortic valve replacement.

    Time frame: 8 years

    We will take a portion of the aortic valve and/or aortic tissue that is routinely excised for aortic valve or aortic replacement for expression analyses and generation of fibroblast cell lines. In collaboration with the Department of Pathology, we have established methods to take sufficient "normal" and abnormal tissue while allowing formal routine pathological evaluation.

    All tissue samples for expression analysis will be transported in iced RNALater and later frozen in a -80°C research freezer, prior to next generation sequencing. We may use tissue samples to develop cell lines for indefinite use.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2019
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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