Rheos Feasibility Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01077180
First received: February 25, 2010
Last updated: October 28, 2011
Last verified: October 2011

February 25, 2010
October 28, 2011
January 2005
December 2007   (final data collection date for primary outcome measure)
Rheos Feasibility Study [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01077180 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rheos Feasibility Trial
Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Device: Implantation of the Rheos System
Open label
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2010
December 2007   (final data collection date for primary outcome measure)

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.

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Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077180
360005-001
Yes
CVRx, Inc.
CVRx, Inc.
Not Provided
Not Provided
CVRx, Inc.
October 2011

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