An observational study in Aortic Regurgitation and Functional Mitral Regurgitation, sponsored by Michele De Bonis. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Michele De Bonis · Observational
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's enrollment of 154 is close to the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Michele De Bonis is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by severe AR and moderate MR. The patients are divided in 2 groups: in the Study group, patients underwent isolated aortic valve surgery, while in the Control group, mitral valve surgery was also added.
Exclusion Criteria:
Procedure: Aortic valve replacement
Procedure: Aortic valve replacement · Procedure: Mitral valve annuloplasty
An aortic valve prosthesis is surgically implanted to treat AR
Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR
Mortality for cardiac causes
Time frame: Through study completion, an average of 7 years
All causes mortality
Time frame: Through study completion, an average of 7 years
Severe AR recurrency
Time frame: Through study completion, an average of 7 years
Reintervention for severe AR recurrency
Time frame: Through study completion, an average of 7 years
Reintervention for severe MR
Time frame: Through study completion, an average of 7 years
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Michele De Bonis