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OpenTrials
Completed

NCT Number: NCT05774808

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic valve replacement

Procedure

An aortic valve prosthesis is surgically implanted to treat AR

mitral valve annuloplasty

Procedure

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

Primary outcomes

  1. Mortality for cardiac causes

    Time frame: Through study completion, an average of 7 years

Secondary outcomes

  1. All causes mortality

    Time frame: Through study completion, an average of 7 years

  2. Severe AR recurrency

    Time frame: Through study completion, an average of 7 years

  3. Reintervention for severe AR recurrency

    Time frame: Through study completion, an average of 7 years

  4. Reintervention for severe MR

    Time frame: Through study completion, an average of 7 years

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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