DRKS00011138CompletedNot Applicable
Hemodynamic and Clinical Monitoring Program During and After the MitraClip® Procedure in Patients with Secondary MR and Advanced Systolic Heart Failure - Mitraclip Conductance
niversitätsklinikum Magdeburg0 sites77 target enrollmentStarted: November 30, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 77
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
Investigators
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