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Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05836363
Enrollment
75
Registered
2023-05-01
Start date
2020-12-04
Completion date
2020-12-09
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascending Aorta Aneurysm, Bicuspid Aortic Valve

Brief summary

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.

Interventions

PROCEDUREAscending aorta replacement

The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adult patients; * Bicuspid aortic valve; * Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020; * Untreated aortic valve disease of no more than moderate degree (\<2+) at the time of ascending aorta surgery.

Exclusion criteria

* Emergency/urgency procedures; * Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery; * Tricuspid aortic valve tricuspid; * Absence of aortic valve disease; * Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.

Design outcomes

Primary

MeasureTime frame
Aortic valve regurgitationThrough study completion, a minimum of 6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026