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

NCT05836363 | Completed

• 1 other identifier: NO SVAO-BAV
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Bicuspid Aortic Valve; Ascending Aorta Aneurysm

Outcome Measures

Primary Outcomes (1)

• Aortic valve regurgitation

  Through study completion, a minimum of 6 months

Interventions

Ascending aorta replacement PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease; Aneurysm, Ascending Aorta

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of the Advanced and Research Therapies

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: May 1, 2023
• Study Start: December 4, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)