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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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-04-28
2031-03-01
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
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
Cephea Mitral Valve System
Transcatheter mitral valve replacement
Interventions
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Cephea Mitral Valve System
Transcatheter mitral valve replacement
Eligibility Criteria
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Inclusion Criteria
* LVEF ≥ 30%
* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
Exclusion Criteria
* Need for emergent or urgent surgery.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Barathi Sethuraman
Role: STUDY_DIRECTOR
Abbott Structural Heart
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center - Moses Division
The Bronx, New York, United States
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Houston Methodist
Houston, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Institut de Cardiologie de Quebec
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABT-CIP-10354
Identifier Type: -
Identifier Source: org_study_id
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