Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Insufficiency
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
- Enrollment
- 105
- Locations
- 6
- Primary Endpoint
- recurrent mitral valve insufficiency > grade 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
recurrent mitral valve insufficiency > grade 2
Time Frame: 2 years
see above
Secondary Outcomes
- MACCE(1 year)
- re-intervention at mitral valve(2 years)
- cardiovascular mortality(2 years)
- device therapy (e. g. left ventricular auxiliary device or heart transplant) due to progressive heart failure(2 years)
- re-hospitalisation due to heart failure(2 years)