Clinical Trials Directory

Trials / Completed

CompletedNCT05774808

Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation

Status
Completed
Phase
Study type
Observational
Enrollment
154 (actual)
Sponsor
Michele De Bonis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case. When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team. To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients. The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.

Conditions

Interventions

TypeNameDescription
PROCEDUREAortic valve replacementAn aortic valve prosthesis is surgically implanted to treat AR
PROCEDUREMitral valve annuloplastySurgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR

Timeline

Start date
2022-02-02
Primary completion
2022-02-23
Completion
2022-02-23
First posted
2023-03-20
Last updated
2023-03-20

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05774808. Inclusion in this directory is not an endorsement.