REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions. (RESURRECT)
Chronic Kidney Diseases, Heart Failure, End Stage Renal Disease
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Renal Denervation, Sympathetic Nervous System
Eligibility Criteria
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.
Sites / Locations
- Royal Perth HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Chronic Kidney Disease
Heart Failure
End stage renal disease
Renal Denervation
Renal Denervation
Renal Denervation