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

Bicuspid Aortic Valve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836363
• Other study ID #: NO SVAO-BAV
• Status: Completed
• Start date: December 4, 2020
• Est. completion date: December 9, 2020

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Disease
• Ascending Aorta Aneurysm
• Bicuspid Aortic Valve
• Bicuspid Aortic Valve Disease
• Heart Valve Diseases

Intervention

Procedure:
• Ascending aorta replacement
The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic valve regurgitation		Through study completion, a minimum of 6 months