Rheos® Pivotal Trial - Full Text View

Sponsor:	CVRx, Inc.
Information provided by (Responsible Party):	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT00442286

Purpose

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 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:

To demonstrate a clinically significant reduction of office cuff systolic blood pressure at six months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To demonstrate a sustained response to therapy through 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
System and procedure related adverse event free rate in the first 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Serious therapy-related adverse event free-rate through 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To compare changes between the Rheos ON and Rheos OFF arms in antihypertensive therapeutic index (ATI) at six months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To demonstrate a clinically significant reduction of 24-hour ambulatory systolic BP at six months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To demonstrate a significant absolute reduction in systolic BP at six months, as measured by office cuff. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To demonstrate a significant absolute reduction in 24-hour ambulatory systolic BP at six months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2012
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Device: Rheos® Baroreflex Hypertension System Electrical activation of the Carotid Baroreflex
Experimental: 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.	Device: Rheos® Baroreflex Hypertension System Electrical activation of the Carotid Baroreflex

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be at least 21 years of age and no more than 80 years of age.
Have been assessed with bilateral carotid bifurcations that are easily interrogated by carotid duplex ultrasound and are below the level of the mandible.
Office cuff systolic blood pressure greater than or equal to 160 mmHg and have a diastolic blood pressure greater than or equal to 80 mmHg as well as a 24-hour ambulatory systolic blood pressure greater than or equal to 135 mmHg despite at lest one month of maximally tolerated therapy with at least three anti-hypertensive medications, of which at least one must be a diuretic.
Must have completed the drug compliance questionnaire and have been judged to be compliant with medications.
For subjects that have had prior bariatric surgery, they must be at least 1 year post-surgery and at a stable weight.
If female, the subject must be surgically sterile, or using a medically accepted method of birth control and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative serum pregnancy test in the pre-implant blood evaluation.
Must be an appropriate or reasonable surgical candidate.
Have signed a CVRx approved informed consent form for participation in this study

Exclusion Criteria:

Have known or suspected baroreflex failure or autonomic neuropathy.
Have an arm circumference greater than 46 cm and/or body mass index of greater than 45.
Have significant cardiac bradyarrhythmias.
Have chronic atrial fibrillation.
Have significant orthostatic hypotension
Had a solid organ or hematologic transplant.
Had a myocardial infarction, unstable angina, syncope, or cerebral vascular accident within the past 3 months.
Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within 6 months of enrollment in the trial.
Have ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
Have prior surgery, radiation, or endovascular stent placement in either carotid sinus region.
Have severe chronic kidney disease as defined by:
- Currently undergoing dialysis or dialysis is planned within 3 months of the implant date
- eGFR of ≤30 ml/min/1.73m²
Have hypertension secondary to an identifiable and treatable cause other than sleep apnea.
Have clinically significant cardiac structural valvular disease.
Have clinically significant reactive airway disease, chronic obstructive pulmonary disease, and/or primary pulmonary hypertension.
Have an uncontrolled comorbid medical condition that would adversely affect participation in the trial.
Have a clinically significant psychological illness that would prohibit the subject's ability to meet the protocol requirements
Are currently taking an imidazolone receptor agonist
Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
Have an active infection within the last month.
Have a co-morbid condition that reduces life expectancy to less than one year.
Are enrolled in another concurrent clinical trial, without prior approval of CVRx.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442286

Show 43 Study Locations

Sponsors and Collaborators

CVRx, Inc.

Investigators

Principal Investigator:	Luis Sanchez, MD	Washington University School of Medicine
Principal Investigator:	Mitra Nadim, MD	University of Southern California

More Information

Additional Information:

Additional information about the Rheos Pivotal Trial for patients and medical professionals can be found at http://www.bloodpressuretrial.com/ This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT00442286 History of Changes
Other Study ID Numbers:	360009-001
Study First Received:	February 27, 2007
Last Updated:	February 8, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by CVRx, Inc.:

Hypertension
High Blood Pressure
Blood Pressure
Cardiovascular Disease

Resistant Hypertension
Stage 2 Hypertension
Hypertension that is resistant to treatment

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 24, 2012