Edwards PASCAL Transcatheter Valve Repair System Registry
NCT ID: NCT04443218
Last Updated: 2024-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
220 participants
OBSERVATIONAL
2019-05-27
2021-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Interventions
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Edwards PASCAL Transcatheter Valve Repair System
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.
Eligibility Criteria
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Inclusion Criteria
* Patient is intended to or has received the PASCAL device
Exclusion Criteria
* Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Joerg Hausleiter, Prof.
Role: PRINCIPAL_INVESTIGATOR
MD
Locations
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LMU Klinikum der Universität München
München, Bavaria, Germany
Immanuel Klinikum Bernau
Bernau bei Berlin, Brandenburg, Germany
Universitätsklinikum Gießen
Giessen, Hesse, Germany
Georg-August-Universität Göttingen, Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany
Herzzentrum Köln
Cologne, Nord Rhine Westphalia, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Herzzentrum der Universitätsklinik Bonn
Bonn, North Rhine-Westphalia, Germany
St.-Johannes-Hospital Dortmund
Dortmund, North Rhine-Westphalia, Germany
Elisabeth-Krankenhaus Essen
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Herzzentrum Universitätsklinik Dresden
Dresden, Saxony, Germany
Heart Centre of the University Leipzig
Leipzig, Saxony, Germany
Kath. Marienkrankenhaus Hamburg GmbH
Hamburg, , Germany
Inselspital Bern
Bern, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-03
Identifier Type: -
Identifier Source: org_study_id
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