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Rheos® Pivotal Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00442286
First received: February 27, 2007
Last updated: January 30, 2017
Last verified: January 2017
Results First Received: November 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Device: Rheos® Baroreflex Hypertension System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 591 patients enrolled, 78 withdrew prior to implant and 187 screen-failed. 4 implants were unsuccessful, and 2 randomized patients were terminated prior to the randomization visit. 55 patients were roll-in patients that were not randomized. A total of 265 patients were both randomized and implanted.

Reporting Groups
  Description
Rheos® Device On

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.

Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex

Rheos® Device Off

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.

Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex


Participant Flow:   Overall Study
    Rheos® Device On   Rheos® Device Off
STARTED   181   84 
6 Months   177   83 
12 Months   174   82 
COMPLETED   174   82 
NOT COMPLETED   7   2 
Death                2                2 
Lost to Follow-up                1                0 
Withdrawal by Subject                2                0 
System explanted                1                0 
Patient Injury                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Roll-In Subjects that were not included in endpoint analyses
Rheos® Device On

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.

Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex

Rheos® Device Off

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.

Rheos® Baroreflex Hypertension System: Electrical activation of the Carotid Baroreflex

Total Total of all reporting groups

Baseline Measures
   Roll-In   Rheos® Device On   Rheos® Device Off   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   181   84   320 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      46  83.6%      151  83.4%      75  89.3%      272  85.0% 
>=65 years      9  16.4%      30  16.6%      9  10.7%      48  15.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      24  43.6%      65  35.9%      38  45.2%      127  39.7% 
Male      31  56.4%      116  64.1%      46  54.8%      193  60.3% 
Race/Ethnicity, Customized 
[Units: Participants]
       
African American   11   30   18   59 
Hispanic   3   2   4   9 
White/Caucasian   40   146   59   245 
Other   1   3   3   7 
Region of Enrollment 
[Units: Participants]
       
Netherlands   0   8   5   13 
United States   55   165   74   294 
Germany   0   8   5   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure   [ Time Frame: 6 months post-activation ]

2.  Primary:   Percent of Group A (Rheos® Device On) Patients Who Maintain a 10 mm Hg Drop in Systolic Blood Pressure at 12 Months Post-activation, and Whose Response at 12 Months is at Least 50% of the Response Observed at 6 Months Post-activation.   [ Time Frame: 12 months post-activation ]

3.  Primary:   Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients   [ Time Frame: 30 days post implant ]

4.  Primary:   Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.   [ Time Frame: 12 months-post activation ]

5.  Primary:   Therapy-related Adverse Event-free Rate.   [ Time Frame: 6 months post-activation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President of Clinical Research
Organization: CVRx
phone: 763-416-2876
e-mail: lgalle@cvrx.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00442286     History of Changes
Other Study ID Numbers: 360009
Study First Received: February 27, 2007
Results First Received: November 18, 2016
Last Updated: January 30, 2017