Rheos® Pivotal Trial

NCT00442286 | Completed Results DMC

• 1 other identifier: 360009
• Study Type: interventional
• Target: 591
• Locations: 3 countries
• Sites: 44

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure; Blood Pressure; Cardiovascular Disease; Resistant Hypertension; Stage 2 Hypertension; Hypertension that is resistant to treatment

Outcome Measures

Primary Outcomes (5)

• Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure

  Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) via a double-blind, randomized, parallel group, super-superiority design for proportion of subjects that achieve at least a 10 mm Hg drop in systolic blood pressure at Month 6 compared to Month 0, with a superiority margin of 20%.

  6 months post-activation

• 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.

  Compare the sustained response in SBP Month 12 in Group A ( Rheos® Device On ) responders at Month 6 to an objective performance criterion of 65%. A sustained response to therapy required the reduction from Month 0 to Month 12 to be at least 10 mmHg and to remain at least 50% of that seen at Month 6.

  12 months post-activation

• Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients

  Compare the serious procedure- or system-related adverse event-free rate for events occurring within 30 days of implant to a pre-specified objective performance criterion of 82% set based on historical literature on implantable cardioverter defibrillators (ICD) and pacemakers. Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort.

  30 days post implant

• Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.

  Compare the event-free rate for all major hypertension-related and serious device-related adverse events occurring between 30 days post-implant and the Month 12 visit, to a pre-specified objective performance criterion of 72% based on similar implantable devices such as defibrillators and resynchronization devices. Note: The purpose of this outcome measure was to evaluate the effect of having the device implanted, not to compare the outcomes between the two treatment groups. Therefore, both groups were analyzed as a single cohort.

  12 months-post activation

• Therapy-related Adverse Event-free Rate.

  Compare Group A (Rheos® Device On ) versus Group B (Rheos® Device Off) therapy-related adverse event-free rates via a double-blind, randomized, parallel group, non-inferiority design for therapy-related serious adverse events occurring between 30 days post-implant and the Month 6 visit. The non-inferiority margin was 15%.

  6 months post-activation

Study Arms (2)

On

EXPERIMENTAL

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

Off

EXPERIMENTAL

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

Interventions

Rheos® Baroreflex Hypertension System DEVICE

Electrical activation of the Carotid Baroreflex

Off; On

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (44)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Apex Cardiology

Inglewood, California, 90301, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

St Joseph Health

Orange, California, 92868, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Florida Hospital Cardiovascular Institute

Orlando, Florida, 32803, United States

Location

Pensacola Research Consultants

Pensacola, Florida, 32504, United States

Location

The Heart and Vascular Institute of Florida

St. Petersburg, Florida, 33709, United States

Location

Florida Cardiovascular Institute

Tampa, Florida, 33609, United States

Location

Southeast Regional Research Group

Columbus, Georgia, 31904, United States

Location

University of Chicago, Dept. of Medicine, Section of Endocinology, Diabetes & Metabolism

Chicago, Illinois, 60637, United States

Location

The Care Group

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

The Center for Cardiovascular Studies, LLC

Shawnee Mission, Kansas, 66204, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Brigham & Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14623, United States

Location

Rex HealthCare

Raleigh, North Carolina, 27607, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State Medical Center

Columbus, Ohio, 43210, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Temple University Health System

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Sanford Clinical Research

Sioux Falls, South Dakota, 57104, United States

Location

Clinical Research Solutions, P.C.

Knoxville, Tennessee, 37920, United States

Location

Saint Thomas Research Institute

Nashville, Tennessee, 37205, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Scott and White Memoral Hospital

Temple, Texas, 76508, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

Related Publications (2)

• Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.

  PMID: 28065708 DERIVED

• de Leeuw PW, Alnima T, Lovett E, Sica D, Bisognano J, Haller H, Kroon AA. Bilateral or unilateral stimulation for baroreflex activation therapy. Hypertension. 2015 Jan;65(1):187-92. doi: 10.1161/HYPERTENSIONAHA.114.04492. Epub 2014 Oct 20.

  PMID: 25331845 DERIVED

Related Links

• Additional information about the Rheos Pivotal Trial for patients and medical professionals can be found at http://www.bloodpressuretrial.com/

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Vice President of Clinical Research
• Organization: CVRx

lgalle@cvrx.com

763-416-2876

Study Officials

• Luis Sanchez, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Mitra Nadim, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: October 1, 2006
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Locations

US (42); DE (1); NL (1)