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

Functional Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774808
• Other study ID #: MOSMIR-SAR
• Status: Completed
• Start date: February 2, 2022
• Est. completion date: February 23, 2022

Study information

• Verified date: March 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency
• Functional Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• Aortic valve replacement
An aortic valve prosthesis is surgically implanted to treat AR
• Mitral valve annuloplasty
Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality for cardiac causes		Through study completion, an average of 7 years
Secondary	All causes mortality		Through study completion, an average of 7 years
Secondary	Severe AR recurrency		Through study completion, an average of 7 years
Secondary	Reintervention for severe AR recurrency		Through study completion, an average of 7 years
Secondary	Reintervention for severe MR		Through study completion, an average of 7 years