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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards Cardioband System | Device | Transcatheter mitral valve repair |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success at discharge | Reduction in Severity of Mitral Regurgitation at discharge | Hospital discharge; approximately 2-8 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | Reduction in Severity of Mitral Regurgitation | 30 days, 6months, 1, 2 and 3 years |
| Major Adverse Events Rate | Rate of Major Adverse Events |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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Symptomatic patients with mitral regurgitation (MR).
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Baldus, MD | Herzzentrum UniKlinik Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herz- und Diabeteszentrum NRW Bad Oeynhausen | Bad Oeynhausen | Germany | ||||
| Berlin Charité - Campus Benjamin Franklin |
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| 30 days, 6months, 1, 2 and 3 years |
| Change in Quality Of Life-KCCQ | Improvements in Quality Of Life as assessed by KCCQ | 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 | 30 days, 6 months, 1, 2 and 3 years |
| Berlin |
| Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Herzzentrum UniKlinik Köln | Cologne | Germany |
| Herzzentrum Universitästklinik Dresden | Dresden | Germany |
| Düsseldorf University Hospital | Düsseldorf | Germany |
| Goethe-University Frankfurt - Surgery Center | Frankfurt am Main | Germany |
| Universitätsmedizin Göttingen | Göttingen | Germany |
| Asklepios Klinik St Georg | Hamburg | Germany |
| Universtitätsmedizin Mainz | Mainz | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Policlinico Vittorio-Emanuelle | Catania | Italy |
| Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio | Massa | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | Italy |
| Policlinico San Donato | San Donato Milanese | Italy |
| University Hospital Zürich | Zurich | Switzerland |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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