| Descriptive Information Fields | |||||||||
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| Brief Title † | Rheos® Pivotal Trial | ||||||||
| Official Title † | Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System | ||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | To demonstrate a clinically significant reduction of office cuff systolic blood pressure at six months. [ Time Frame: 6 months ] To demonstrate a sustained response to therapy through 12 months. [ Time Frame: 12 months ] System and procedure related adverse event free rate in the first 30 days. [ Time Frame: 30 days ] Hypertension-related adverse event and serious device-related adverse event free rate more than 30 days post-implant to 13 months. [ Time Frame: 13 months ] Serious therapy-related adverse event free-rate through 6 months. [ Time Frame: 6 months ] |
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| Secondary Outcome Measure † | To compare changes between the Rheos ON and Rheos OFF arms in antihypertensive therapeutic index (ATI) at six months. [ Time Frame: 6 months ] To demonstrate a clinically significant reduction of 24-hour ambulatory systolic BP at six months. [ Time Frame: 6 months ] To demonstrate a significant absolute reduction in systolic BP at six months, as measured by office cuff. [ Time Frame: 6 months ] To demonstrate a significant absolute reduction in 24-hour ambulatory systolic BP at six months. [ Time Frame: 6 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. [ Time Frame: 12 months ] |
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| Condition † | Hypertension | ||||||||
| Intervention † | Device: Rheos® Baroreflex Hypertension System | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | Additional information about the Rheos Pivotal Trial for patients and medical professionals can be found at http://www.bloodpressuretrial.com/ ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | October 2006 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States, Germany, Netherlands | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00442286 | ||||||||
| Organization ID | 360009-001 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | CVRx, Inc. | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | CVRx, Inc. | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | February 27, 2007 | ||||||||
| Last Updated Date | October 24, 2008 | ||||||||