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
19 participants
INTERVENTIONAL
2009-08-31
2021-04-01
Brief Summary
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Detailed Description
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The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device
Rheos® system
Rheos® system
Implant procedure
Medical Management
Medical Management Therapy
No interventions assigned to this group
Interventions
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Rheos® system
Implant procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study.
Exclusion Criteria
21 Years
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Fred Weaver, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Michael Zile, MD
Role: STUDY_CHAIR
Medical University of South Carolina
Faiez Zannad, MD
Role: PRINCIPAL_INVESTIGATOR
Inserm Centre d'Investigation, CHU de Nancy
JoAnn Lindenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt Heart and Vascular Institute
Locations
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Cardiology Associates of Mobile, Inc.
Mobile, Alabama, United States
Apex Cardiology Consultants
Inglewood, California, United States
University of Southern California
Los Angeles, California, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
Florida Hospital Cardiovascular Institute/Florida Heart Group
Orlando, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States
Florida Cardiovascular Institute
Tampa, Florida, United States
The Care Group
Indianapolis, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Liberty Cardiovascular Specialists
Liberty, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Forsyth Cardiovascular Research
Winston-Salem, North Carolina, United States
Lindner Research Center
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Northwest Ohio Cardiology Consultants
Toledo, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Drexel University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29.
Other Identifiers
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360017-001
Identifier Type: -
Identifier Source: org_study_id
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