Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-06-06
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Edwards Cardioband System
Transcatheter mitral valve repair
Eligibility Criteria
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Inclusion Criteria
* MR (≥ 2+ by echocardiography);
* Patient is eligible to receive the Edwards Cardioband Mitral System
Exclusion Criteria
* Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue
* Heavily calcified annulus or leaflets
* Patients in whom transesophageal echocardiography is contraindicated
* Patients who cannot tolerate an anticoagulation/antiplatelet regimen
* Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated.
* Pre-existing prosthetic heart valve or annuloplasty in the Mitral position
* Life expectancy of less than twelve months
* Patient is pregnant or lactating
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Baldus, MD
Role: PRINCIPAL_INVESTIGATOR
Herzzentrum UniKlinik Köln
Locations
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Herz- und Diabeteszentrum NRW Bad Oeynhausen
Bad Oeynhausen, , Germany
Berlin Charité - Campus Benjamin Franklin
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
Countries
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Other Identifiers
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2017-10
Identifier Type: -
Identifier Source: org_study_id
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