Rheos Feasibility Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01077180|
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : October 19, 2016
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension|
|Study Start Date :||January 2005|
|Primary Completion Date :||December 2007|
|Study Completion Date :||October 2010|
|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.
- 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.