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Rheos Feasibility Trial

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ClinicalTrials.gov Identifier: NCT01077180
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.

Condition or disease Intervention/treatment Phase
Hypertension Device: Implantation of the Rheos System Other: Standard of care medical management Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension
Study Start Date : January 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: Rheos Device Device: Implantation of the Rheos System
Open label
Active Comparator: Medical Management Other: Standard of care medical management
Patients will continue with medical therapy for standard of care of their hypertension.



Primary Outcome Measures :
  1. Rheos Feasibility Study [ Time Frame: 13 months ]

    To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant).

    To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant.




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

Inclusion Criteria:

  1. Be at least 21 years of age.
  2. Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
  3. Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
  4. Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
  5. Have signed a CVRx approved informed consent for participation in this study.

Exclusion Criteria:

  1. Have been diagnosed with:

    • Baroreflex failure
    • Cardiac bradyarrhythmias
    • Chronic atrial fibrillation
  2. Had a heart transplant
  3. Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
  4. Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
  5. Have prior surgery or radiation in either carotid sinus region.
  6. Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
  7. Are pregnant or contemplating pregnancy during the 13-month follow-up period.
  8. Currently undergoing dialysis.
  9. Have hypertension secondary to a treatable cause.
  10. Have clinically significant cardiac valvular disease.
  11. Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
  12. Are unlikely to survive the protocol follow-up period.
  13. Are enrolled in another concurrent clinical trial.


Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01077180     History of Changes
Other Study ID Numbers: 360005-001
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases