Overview
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)
Description
There is unequivocal evidence for an important contribution of increased renal sympathetic nerve activity to cardiovascular (CV) morbidity and mortality in high risk patient cohorts with CKD, ESRD and HF. The availability of a highly effective catheter-based ultrasound device to selectively target renal nerves provides a potential unique opportunity to improve CV outcomes in these patients, a proposition that now needs to be tested in initial pilot trials and subsequent appropriately designed randomized controlled trials.
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.