Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Rheos® Pivotal Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00442286
First received: February 27, 2007
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a diuretic.

Condition Intervention
Hypertension
Device: Rheos® Baroreflex Hypertension System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure [ Time Frame: 6 months post-activation ]
    Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.

  • Percent of Group A (Rheos® Device On) Patients Who Maintain a 10 mm Hg Drop in Systolic Blood Pressure at 12 Months Post-activation, and Whose Response at 12 Months is at Least 50% of the Response Observed at 6 Months Post-activation. [ Time Frame: 12 months post-activation ]
    Compare the sustained response in SBP Month 12 in Group A ( Rheos® Device On ) responders at Month 6 to an objective performance criterion of 65%. A sustained response to therapy required the reduction from Month 0 to Month 12 to be at least 10 mmHg and to remain at least 50% of that seen at Month 6.

  • Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients [ Time Frame: 30 days post implant ]

    Compare the serious procedure- or system-related adverse event-free rate for events occurring within 30 days of implant to a pre-specified objective performance criterion of 82% set based on historical literature on implantable cardioverter defibrillators (ICD) and pacemakers.

    Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort.


  • Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients. [ Time Frame: 12 months-post activation ]

    Compare the event-free rate for all major hypertension-related and serious device-related adverse events occurring between 30 days post-implant and the Month 12 visit, to a pre-specified objective performance criterion of 72% based on similar implantable devices such as defibrillators and resynchronization devices.

    Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort.


  • Therapy-related Adverse Event-free Rate. [ Time Frame: 6 months post-activation ]
    Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) therapy-related adverse event-free rates via a double-blind, randomized, parallel group, non-inferiority design for therapy-related serious adverse events occurring between 30 days post-implant and the Month 6 visit. The non-inferiority margin was 15%.


Enrollment: 591
Study Start Date: October 2006
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
Experimental: 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.
Device: Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 21 years of age and no more than 80 years of age.
  • 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 known or suspected baroreflex failure or autonomic neuropathy.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442286

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Apex Cardiology
Inglewood, California, United States, 90301
University of Southern California
Los Angeles, California, United States, 90033
St Joseph Health
Orange, California, United States, 92868
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
VA Medical Center
Washington, District of Columbia, United States, 20422
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Florida Hospital Cardiovascular Institute
Orlando, Florida, United States, 32803
Pensacola Research Consultants
Pensacola, Florida, United States, 32504
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States, 33709
Florida Cardiovascular Institute
Tampa, Florida, United States, 33609
United States, Georgia
Southeast Regional Research Group
Columbus, Georgia, United States, 31904
United States, Illinois
University of Chicago, Dept. of Medicine, Section of Endocinology, Diabetes & Metabolism
Chicago, Illinois, United States, 60637
United States, Indiana
The Care Group
Indianapolis, Indiana, United States, 46290
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Kansas
The Center for Cardiovascular Studies, LLC
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Brigham & Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University
St.Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14623
United States, North Carolina
Rex HealthCare
Raleigh, North Carolina, United States, 27607
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Ohio State Medical Center
Columbus, Ohio, United States, 43210
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Temple University Health System
Philadelphia, Pennsylvania, United States, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Dakota
Sanford Clinical Research
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Clinical Research Solutions, P.C.
Knoxville, Tennessee, United States, 37920
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Scott and White Memoral Hospital
Temple, Texas, United States, 76508
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Germany
Medizinische Hochschule Hannover
Hannover, Germany
Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
CVRx, Inc.
Investigators
Principal Investigator: Luis Sanchez, MD Washington University School of Medicine
Principal Investigator: Mitra Nadim, MD University of Southern California
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00442286     History of Changes
Other Study ID Numbers: 360009
Study First Received: February 27, 2007
Results First Received: November 18, 2016
Last Updated: January 30, 2017

Keywords provided by CVRx, Inc.:
Hypertension
High Blood Pressure
Blood Pressure
Cardiovascular Disease
Resistant Hypertension
Stage 2 Hypertension
Hypertension that is resistant to treatment

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 25, 2017