Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CVRx, Inc.
Age
21–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
