REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.

Exclusion Criteria10

• Ineligible anatomy
• Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device.
• Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
• Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
• Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
• Individual has been admitted for inpatient hospitalization for decompensated HF in the previous month
• Female participants of childbearing potential must have a negative pregnancy test prior to treatment.
• Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
• Individual is currently enrolled in another investigational drug or device trial. Note: For the purpose of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
• Individual has a disease or condition (aside from CKD, ESRD, and HFrEF) that may limit their life expectancy to \< 1 year.