Study Results
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View full resultsBasic Information
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COMPLETED
NA
591 participants
INTERVENTIONAL
2006-10-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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On
Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
Off
Subject will be randomized to a 2:1 allocation to the Rheos ON or OFF arms at the time of Rheos System activation (time point 0). After the six month follow up evaluation, all subjects will have therapy activated, though subjects and treating physicians will not be informed of randomized treatment assignment.
Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
Interventions
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Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
Eligibility Criteria
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Inclusion Criteria
* Have been assessed with bilateral carotid bifurcations that are easily interrogated by carotid duplex ultrasound and are below the level of the mandible.
* Office cuff systolic blood pressure greater than or equal to 160 mmHg and have a diastolic blood pressure greater than or equal to 80 mmHg as well as a 24-hour ambulatory systolic blood pressure greater than or equal to 135 mmHg despite at lest one month of maximally tolerated therapy with at least three anti-hypertensive medications, of which at least one must be a diuretic.
* Must have completed the drug compliance questionnaire and have been judged to be compliant with medications.
* For subjects that have had prior bariatric surgery, they must be at least 1 year post-surgery and at a stable weight.
* If female, the subject must be surgically sterile, or using a medically accepted method of birth control and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative serum pregnancy test in the pre-implant blood evaluation.
* Must be an appropriate or reasonable surgical candidate.
* Have signed a CVRx approved informed consent form for participation in this study
Exclusion Criteria
* Have an arm circumference greater than 46 cm and/or body mass index of greater than 45.
* Have significant cardiac bradyarrhythmias.
* Have chronic atrial fibrillation.
* Have significant orthostatic hypotension
* Had a solid organ or hematologic transplant.
* Had a myocardial infarction, unstable angina, syncope, or cerebral vascular accident within the past 3 months.
* Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within 6 months of enrollment in the trial.
* Have ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
* Have prior surgery, radiation, or endovascular stent placement in either carotid sinus region.
* Have severe chronic kidney disease as defined by:
* Currently undergoing dialysis or dialysis is planned within 3 months of the implant date
* eGFR of ≤30 ml/min/1.73m²
* Have hypertension secondary to an identifiable and treatable cause other than sleep apnea.
* Have clinically significant cardiac structural valvular disease.
* Have clinically significant reactive airway disease, chronic obstructive pulmonary disease, and/or primary pulmonary hypertension.
* Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
* Have a clinically significant psychological illness that would prohibit the subject's ability to meet the protocol requirements
* Are currently taking an imidazolone receptor agonist
* Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
* Have an active infection within the last month.
* Have a co-morbid condition that reduces life expectancy to less than one year.
* Are enrolled in another concurrent clinical trial, without prior approval of CVRx.
21 Years
80 Years
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Luis Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Mitra Nadim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Apex Cardiology
Inglewood, California, United States
University of Southern California
Los Angeles, California, United States
St Joseph Health
Orange, California, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
VA Medical Center
Washington D.C., District of Columbia, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Florida Hospital Cardiovascular Institute
Orlando, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States
Florida Cardiovascular Institute
Tampa, Florida, United States
Southeast Regional Research Group
Columbus, Georgia, United States
University of Chicago, Dept. of Medicine, Section of Endocinology, Diabetes & Metabolism
Chicago, Illinois, United States
The Care Group
Indianapolis, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
The Center for Cardiovascular Studies, LLC
Shawnee Mission, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Rex HealthCare
Raleigh, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio State Medical Center
Columbus, Ohio, United States
Jobst Vascular Center
Toledo, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Temple University Health System
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Sanford Clinical Research
Sioux Falls, South Dakota, United States
Clinical Research Solutions, P.C.
Knoxville, Tennessee, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Scott and White Memoral Hospital
Temple, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Medizinische Hochschule Hannover
Hanover, , Germany
University Hospital Maastricht
Maastricht, , Netherlands
Countries
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References
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Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.
de Leeuw PW, Alnima T, Lovett E, Sica D, Bisognano J, Haller H, Kroon AA. Bilateral or unilateral stimulation for baroreflex activation therapy. Hypertension. 2015 Jan;65(1):187-92. doi: 10.1161/HYPERTENSIONAHA.114.04492. Epub 2014 Oct 20.
Related Links
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Additional information about the Rheos Pivotal Trial for patients and medical professionals can be found at http://www.bloodpressuretrial.com/
Other Identifiers
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360009
Identifier Type: -
Identifier Source: org_study_id
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