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

Completed

• Conditions: Bicuspid Aortic Valve; Ascending Aorta Aneurysm

• Registration Number: NCT05836363
• Lead Sponsor: Michele De Bonis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-04
• Primary Completion: 2020-12-09
• Study Completion: 2020-12-09
• Study First Submitted: 2023-01-30
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aortic valve regurgitation	Through study completion, a minimum of 6 months

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy