Rheos Feasibility Trial
|Hypertension||Device: Implantation of the Rheos System Other: Standard of care medical management||Phase 2|
|Study Design:||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|
- 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.
|Study Start Date:||January 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Experimental: Rheos Device||
Device: Implantation of the Rheos System
|Active Comparator: Medical Management||
Other: Standard of care medical management
Patients will continue with medical therapy for standard of care of their hypertension.