N/A N=265 Randomized Quadruple-blind Treatment

Rheos® Pivotal Trial

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00442286 ↗

Enrolled (actual)

265

Serious AEs

55.5%

Results posted

Mar 2017

Primary outcome: Primary: Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure — 54.1; 46.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Rheos® Baroreflex Hypertension System (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: CVRx, Inc.
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Patients With a 10mmHg or Greater Reduction in Office Cuff Systolic Blood Pressure	54.1; 46.4	—
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.	87.6	—
PRIMARY Serious Procedure- or System-related Adverse Event-free Rate in Both Implanted and Attempted Patients	74.8	—
PRIMARY Major Hypertension-related and Serious Device-related Adverse Event-Free Rate in Both Implanted and Attempted Patients.	87.2	—
PRIMARY Therapy-related Adverse Event-free Rate.	91.7; 89.3	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00442286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.