Hemodynamic and Clinical Monitoring Program During and After the MitraClip® Procedure in Patients with Secondary MR and Advanced Systolic Heart Failure
- Conditions
- I50I34Heart failureNonrheumatic mitral valve disorders
- Registration Number
- DRKS00011138
- Lead Sponsor
- niversitätsklinikum Magdeburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
Age >18 years
-Systolic heart failure, EF < 25%, NYHA III/IV
-Severe functional mitral regurgitation according to ACC/AHA guidelines: ERO = 20 mm2, regurgitant fraction = 50%, regurgitant volume = 30ml
-Clinical indication for MitraClip® Implantation
-Cardiac index = 2.1 l/min/qm
-Signed written informed consent
Exclusion Criteria
-Myocardial infarction within the last 3 months
-Consuming tumor with an expected life expectancy < 12 months
-Impossibility of MitraClip®-Implantation
-Inability to follow instructions or comply with follow-up procedures, e.g. 6-minute-Walking Test
-Pregnancy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This approach will help to find MR-dependent and independent predictors for the acute and chronic clinical and myocardial response (left ventricular remodelling) of Mitraclip® therapy in advanced systolic heart failure patients.
- Secondary Outcome Measures
Name Time Method