Trials / Completed
CompletedNCT05774808
Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 154 (actual)
- Sponsor
- Michele De Bonis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-02-02
- Primary completion
- 2022-02-23
- Completion
- 2022-02-23
- First posted
- 2023-03-20
- Last updated
- 2023-03-20
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05774808. Inclusion in this directory is not an endorsement.