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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COMPLETED
NA
157 participants
INTERVENTIONAL
2017-03-08
2024-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
TIARA valve and transapical delivery system
Transcatheter mitral valve replacement
Interventions
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TIARA valve and transapical delivery system
Transcatheter mitral valve replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High surgical risk for open mitral valve surgery
* Subject meets anatomical eligibility criteria
Exclusion Criteria
* Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
* Unsuitable cardiac structure
* Clinically significant untreated Coronary Artery Disease (CAD)
* Subjects on chronic dialysis
* Pregnant or planning pregnancy within next 12 months
* Documented bleeding or coagulation disorders
* Active infections requiring antibiotic therapy
* Subjects with a life expectancy less than 12 months
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Kerckhoff Klinik Herzzentrum-Herzchirurgie
Bad Nauheim, , Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Schüchtermann-Klinik
Bad Rothenfelde, , Germany
Deutches Herzzentrum Berlin
Berlin, , Germany
Immanuel Klinikum Bernau und Herzzentrum Brandenburg
Bernau, , Germany
St.-Johannes-Hospital, Klinik für Innere Medizin I
Dortmund, , Germany
Universitätsklinikum Halle
Halle, , Germany
Universitasklinikum Hamburg-Eppendorf
Hamburg, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
Rotenburg an der Fulda, , Germany
Sana Herzchirurgie Stuttgart GmbH
Stuttgart, , Germany
Tel Aviv Medical Center
Tel Aviv, , Israel
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
Roma, RM, Italy
Fondazione Toscana 'Gabriele Monasterio'
Massa, , Italy
Ospedale San Raffaele
Milan, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
St. Antonius Hospital
Nieuwegein, , Netherlands
Hospital Clinico San Carlos
Madrid, , Spain
Edinburgh Heart Centre Royal Infirmary
Edinburgh, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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Related Links
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Company website with product information
Other Identifiers
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047-CPT-003
Identifier Type: -
Identifier Source: org_study_id
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