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

Summary

The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)

Eligibility

Inclusion Criteria:

* Both Male and female patients
* Ages between 18-75 years of age
* Individual is competent and willing to provide written, informed consent to participate in this clinical study with either

  * CKD stage 3a/b or
  * ESRD on stable renal replacement therapy or
  * Mild to moderate heart failure with reduced ejection fraction

Exclusion Criteria:

* 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.

Conditions4

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