An observational study in Bicuspid Aortic Valve and Ascending Aorta Aneurysm, sponsored by Michele De Bonis. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by Michele De Bonis · Observational
Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.
There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract.
The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.
231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.
This study's enrollment of 75 is below the median of 200 across 112 observational studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Michele De Bonis is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with bicuspid aortic valve and supra-coronaric ascending aorta aneurysm requiring ascending aorta replacement. Aortic valve regurgitation is no more than moderate, so it is left untreated following the guidelines.
Exclusion Criteria:
The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis
Aortic valve regurgitation
Time frame: Through study completion, a minimum of 6 months
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Michele De Bonis