Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function

Study Overview
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Brief Summary
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Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention, particularly because they are frequently associated with left ventricular (LV) dilation and reduced LV ejection fraction (EF). The registry will document the underlying pathology by using transthoracal echo cardiography (TTE) with analysis of common tenting parameters. OP strategies, data and outcomes will be documented, as well as follow-up data for echocardiography, quality of life and MACCE outcomes after 6 months, 1 and 2 years.

Detailed Description
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Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry. Exact analysis of the underlying pathology using TTE with analysis of tenting parameters. In patients without contraindications, functional preoperative MRT to determine the functional reserve of ventricular function. Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention. Documentation of follow-up data (SF12, TTE, NT-pro BNP) at 6 months, 1 and 2 years. Development of operative strategies to improve long-term outcomes in patients with severe LV dilation (typically accompanied by function mitral insufficiency type IIIb).

Official Title
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Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion

Conditions
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Mitral Valve Insufficiency, Left Ventricular Systolic Dysfunction, Mitral Valve Prolapse

Intervention / Treatment
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* Procedure: mitral valve repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) - effective regurgitation orifice area > 20 mm2 / regurgitant volume > 30 ml/beat left ventricular ejection fraction <= 50% and /or left ventricular end-diastolic diameter >= 60 mm tenting of the proximal and / or anterior mitral leaflets Exclusion Criteria: prolaps of leaflets (type II mitral regurgitation) combination intervention with aortic valve repair or replacement re-operation at mitral valve

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| functional mitral insufficiency op<br>Patients with functional mitral insufficiency with restricted leaflet movement during systole (type IIIb Carpentier) undergoing operative reconstruction (mitral valve repair) | Procedure: mitral valve repair<br>* operative reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent mitral valve insufficiency > grade 2 | see above | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | major adverse cardiovascular and cerebrovascular events | 1 year | 
| re-intervention at mitral valve | see above | 2 years | 
| device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure | see above | 2 years | 
| cardiovascular mortality | see above | 2 years | 
| re-hospitalisation due to heart failure | see above | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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annuloplasty mitral valve, reduced LV function