Rheos® Pivotal Trial

Hypertension Clinical Trial

Official title:

Rheos® Pivotal Trial: Rheos™ Baroreflex Hypertension Therapy System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442286
• Other study ID #: 360009
• Status: Completed
• Phase: N/A
• First received: February 27, 2007
• Last updated: July 22, 2016
• Start date: October 2006
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover
Netherlands	University Hospital Maastricht	Maastricht
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Womens Hospital	Boston	Massachusetts
United States	University of Chicago, Dept. of Medicine, Section of Endocinology, Diabetes & Metabolism	Chicago	Illinois
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Ohio State Medical Center	Columbus	Ohio
United States	Southeast Regional Research Group	Columbus	Georgia
United States	Henry Ford Health System	Detroit	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	The Care Group	Indianapolis	Indiana
United States	Apex Cardiology	Inglewood	California
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Clinical Research Solutions, P.C.	Knoxville	Tennessee
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	University of Southern California	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	St Joseph Health	Orange	California
United States	Florida Hospital Cardiovascular Institute	Orlando	Florida
United States	Pensacola Research Consultants	Pensacola	Florida
United States	Temple University Health System	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Rex HealthCare	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	Swedish Medical Center	Seattle	Washington
United States	The Center for Cardiovascular Studies, LLC	Shawnee Mission	Kansas
United States	Sanford Clinical Research	Sioux Falls	South Dakota
United States	The Heart and Vascular Institute of Florida	St. Petersburg	Florida
United States	Washington University	St.Louis	Missouri
United States	Florida Cardiovascular Institute	Tampa	Florida
United States	Scott and White Memoral Hospital	Temple	Texas
United States	Jobst Vascular Center	Toledo	Ohio
United States	George Washington University Hospital	Washington	District of Columbia
United States	VA Medical Center	Washington	District of Columbia
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate a clinically significant reduction of office cuff systolic blood pressure at six months.		6 months	No
Primary	To demonstrate a sustained response to therapy through 12 months.		12 months	No
Primary	System and procedure related adverse event free rate in the first 30 days.		30 days	Yes
Primary	Hypertension-related adverse event and serious device-related adverse event free rate more than 30 days post-implant to 13 months.		13 months	Yes
Primary	Serious therapy-related adverse event free-rate through 6 months.		6 months	Yes
Secondary	To compare changes between the Rheos ON and Rheos OFF arms in antihypertensive therapeutic index (ATI) at six months.		6 months	No
Secondary	To demonstrate a clinically significant reduction of 24-hour ambulatory systolic BP at six months.		6 months	No
Secondary	To demonstrate a significant absolute reduction in systolic BP at six months, as measured by office cuff.		6 months	No
Secondary	To demonstrate a significant absolute reduction in 24-hour ambulatory systolic BP at six months.		6 months	No
Secondary	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.		12 months	No