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

Sponsor
Michele De Bonis (Other)
Overall Status
Completed
CT.gov ID
NCT05774808
Collaborator
(none)
154
1
21
223.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Aortic valve replacement
  • Procedure: Mitral valve annuloplasty

Study Design

Study Type:
Observational
Actual Enrollment :
154 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
Actual Study Start Date :
Feb 2, 2022
Actual Primary Completion Date :
Feb 23, 2022
Actual Study Completion Date :
Feb 23, 2022

Arms and Interventions

Arm Intervention/Treatment
Aortic valve surgery only

Procedure: Aortic valve replacement
An aortic valve prosthesis is surgically implanted to treat AR

Aortic valve + mitral valve surgery

Procedure: Aortic valve replacement
An aortic valve prosthesis is surgically implanted to treat AR

Procedure: Mitral valve annuloplasty
Surgical repair of the mitral valve in which a prosthetic ring is implanted to treat MR

Outcome Measures

Primary Outcome Measures

  1. Mortality for cardiac causes [Through study completion, an average of 7 years]

Secondary Outcome Measures

  1. All causes mortality [Through study completion, an average of 7 years]

  2. Severe AR recurrency [Through study completion, an average of 7 years]

  3. Reintervention for severe AR recurrency [Through study completion, an average of 7 years]

  4. Reintervention for severe MR [Through study completion, an average of 7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Ospedale San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT05774808
Other Study ID Numbers:
  • MOSMIR-SAR
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 20, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2023