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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04149600
Other study ID # 2018P000380
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2018
Est. completion date June 30, 2027

Study information

Verified date November 2023
Source Beth Israel Deaconess Medical Center
Contact Simon C Robson, MD, PhD
Phone 617-735-2921
Email srobson@bidmc.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 30, 2027
Est. primary completion date June 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
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.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
8 years
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