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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05774808
Enrollment
154
Registered
2023-03-20
Start date
2022-02-02
Completion date
2022-02-23
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Regurgitation, Functional Mitral Regurgitation

Brief 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.

Interventions

PROCEDUREAortic valve replacement

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

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients; * Patients with severe aortic regurgitation (AR) AND moderate mitral regurgitation (MR). * Patients underwent isolated aortic valve surgery (Study Group) or concomitant mitral valve surgery (Control Group) and * Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from January 2004 to January 2019

Exclusion criteria

* Patient with more than moderate MR

Design outcomes

Primary

MeasureTime frame
Mortality for cardiac causesThrough study completion, an average of 7 years

Secondary

MeasureTime frame
All causes mortalityThrough study completion, an average of 7 years
Severe AR recurrencyThrough study completion, an average of 7 years
Reintervention for severe AR recurrencyThrough study completion, an average of 7 years
Reintervention for severe MRThrough study completion, an average of 7 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026