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Sponsored by: |
CVRx, Inc. |
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Information provided by: | CVRx, Inc. |
ClinicalTrials.gov Identifier: | NCT00442286 |
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 | Phase |
---|---|---|
Hypertension |
Device: Rheos® Baroreflex Hypertension System |
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 |
Official Title: | Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System |
Estimated Enrollment: | 300 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
---|---|
On: Experimental
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.
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Device: Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
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Off: Experimental
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.
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Device: Rheos® Baroreflex Hypertension System
Electrical activation of the Carotid Baroreflex
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Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Have severe chronic kidney disease as defined by:
Contact: Tom Moore | (763) 416-2352 | tmoore@cvrx.com |
Contact: Lisa Grant | (763) 416-2876 | lgrant@cvrx.com |
Principal Investigator: | Thomas Pickering, MD | Columbia University Dept. of Medicine |
Principal Investigator: | Luis Sanchez, MD | Washington University School of Medicine |
Study ID Numbers: | 360009-001 |
Study First Received: | February 27, 2007 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00442286 |
Health Authority: | United States: Food and Drug Administration |
Hypertension High Blood Pressure Blood Pressure Cardiovascular Disease |
Resistant Hypertension Stage 2 Hypertension Hypertension that is resistant to treatment |
Vascular Diseases Hypertension |
Cardiovascular Diseases |