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

April 28, 2023 updated by: Michele De Bonis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Ascending aorta replacement

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Milan, Italy, 20132
    - IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aortic valve regurgitation Time Frame: Through study completion, a minimum of 6 months	Through study completion, a minimum of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michele De Bonis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Actual)

December 9, 2020

Study Completion (Actual)

December 9, 2020

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)