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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
February 27, 2007
January 30, 2017
October 2006
January 2016   (Final data collection date for primary outcome measure)
  • 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%.
  • To demonstrate a clinically significant reduction of office cuff systolic blood pressure at six months.
  • To demonstrate a sustained response to therapy through 12 months.
  • System and procedure related adverse event free rate in the first 30 days.
  • Hypertension-related adverse event and serious device-related adverse event free rate more than 30 days post-implant to 13 months.
  • Serious therapy-related adverse event free-rate through 6 months.
Complete list of historical versions of study NCT00442286 on ClinicalTrials.gov Archive Site
Not Provided
  • To compare changes between the Rheos ON and Rheos OFF arms in antihypertensive therapeutic index (ATI) at six months.
  • To demonstrate a clinically significant reduction of 24-hour ambulatory systolic BP at six months.
  • To demonstrate a significant absolute reduction in systolic BP at six months, as measured by office cuff.
  • To demonstrate a significant absolute reduction in 24-hour ambulatory systolic BP at six months.
  • To further demonstrate sustained response to therapy by evaluating an immediate (randomized to ON) vs. deferred (randomized to OFF) therapy comparison of average absolute reduction in systolic BP as measured by office cuff at 12 months.
Not Provided
Not Provided
 
Rheos® Pivotal Trial
Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
Device: Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
  • 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.
    Intervention: Device: Rheos® Baroreflex Hypertension System
  • 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.
    Intervention: Device: Rheos® Baroreflex Hypertension System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
591
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   United States
 
 
NCT00442286
360009
Yes
Not Provided
Not Provided
CVRx, Inc.
CVRx, Inc.
Not Provided
Principal Investigator: Luis Sanchez, MD Washington University School of Medicine
Principal Investigator: Mitra Nadim, MD University of Southern California
CVRx, Inc.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP