Mitral Regurgitation Clinical Trial
Official title:
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
NCT number | NCT05836480 |
Other study ID # | SUB-MVR |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2019 |
Est. completion date | October 15, 2019 |
Verified date | April 2023 |
Source | Ospedale San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease. Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+). The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study
Status | Completed |
Enrollment | 141 |
Est. completion date | October 15, 2019 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Study group: - presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013; - presence of moderate residual mitral regurgitation at discharge. - Control group: - presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013; - presence of residual mitral regurgitation of at least mild grade at discharge. Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Ospedale San Raffaele | Milan |
Lead Sponsor | Collaborator |
---|---|
Michele De Bonis |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | through study completion, a minimum of 6 years |
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