A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
NCT ID: NCT02478008
Last Updated: 2016-03-31
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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TERMINATED
NA
2 participants
INTERVENTIONAL
2015-06-30
2015-08-31
Brief Summary
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The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CardiAQ TMVI System (Transapical DS)
CardiAQ TMVI System (Transapical DS)
Interventions
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CardiAQ TMVI System (Transapical DS)
Eligibility Criteria
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Inclusion Criteria
* Left Ventricular Ejection Fraction ≥ 30%
* Mitral regurgitation ≥ Grade 3+
* Subject meets anatomical eligibility criteria for the investigational device
65 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Søndergaard, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet University Hospital (Copenhagen, Denmark)
Locations
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Rigshospitalet University Hospital
Copenhagen, , Denmark
Centre hospitalier régional universitaire de Lille
Lille, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Centre Hospitalier Universiatier de Toulouse
Toulouse, , France
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Leeds General Infirmary
Leeds, , United Kingdom
New Cross Hospital Heart Center
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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CIP-3102-01
Identifier Type: -
Identifier Source: org_study_id