An observational study in Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve and Aortic Valve Disease, sponsored by Beth Israel Deaconess Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Beth Israel Deaconess Medical Center · Observational
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.
44 studies on the registry are indexed under Aortic Valve, Calcification of; 15 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 225 across 20 observational studies indexed under Aortic Valve, Calcification of.
Browse Aortic Valve, Calcification of studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
The investigators wish to identify the molecular genetic causes of the variability in development of calcific aortic valve disease and aortic dilation in patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery at BIDMC.
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Exclusion Criteria:
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.
Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
Data and samples will be compared using a control group comprised of patients with a tricuspid aortic valve undergoing aortic surgery.
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.
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.
Time frame: 8 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2018 (actual). Primary completion is estimated for Jun 2027, 105 months after the start.
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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