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

NCT ID: NCT05836363

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-04

Study Completion Date

2020-12-09

Brief Summary

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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

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Conditions

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Bicuspid Aortic Valve Ascending Aorta Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Ascending aorta replacement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele De Bonis

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Chief of Cardiac Surgery of the Advanced and Research Therapies

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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NO SVAO-BAV

Identifier Type: -

Identifier Source: org_study_id

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