To demonstrate reduction of MR with durable performance and im-provements in functional status
MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.
Study Type
OBSERVATIONAL
Enrollment
200
Transcatheter mitral valve repair
Herz- und Diabeteszentrum NRW Bad Oeynhausen
Bad Oeynhausen, Germany
Berlin Charité - Campus Benjamin Franklin
Berlin, Germany
Procedure Success at discharge
Reduction in Severity of Mitral Regurgitation at discharge
Time frame: Hospital discharge; approximately 2-8 days post-procedure
Procedure Success
Reduction in Severity of Mitral Regurgitation
Time frame: 30 days, 6months, 1, 2 and 3 years
Major Adverse Events Rate
Rate of Major Adverse Events
Time frame: 30 days, 6months, 1, 2 and 3 years
Change in Quality Of Life-KCCQ
Improvements in Quality Of Life as assessed by KCCQ
Time frame: 30 days, 6 months, 1, 2 and 3 years
Change in Quality Of Life-EQ-5D-5L
Improvements in Quality Of Life as assessed by EQ-5D-5L
Time frame: 30 days, 6 months, 1, 2 and 3 years
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...and 7 more locations