End Stage Renal Disease
Conditions
Brief summary
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* adult \>= 18 years of age * end stage renal disease, undergoing concurrent dialysis treatment * poorly controlled blood pressure on at least 2 antihypertensive drugs * agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits * competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion criteria
* renal arterial abnormalities * myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months * hemodynamically significant valvular heart disease * implantable cardioverter defibrillator (ICD) or pacemaker * respiratory support. * pregnant, nursing or planning to be pregnant * other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide confirmation that renal denervation in ESRD patients is safe and feasible. | — |
Secondary
| Measure | Time frame |
|---|---|
| To provide evidence of denervation, indication of physiologic response, and assess device performance. | — |
Countries
Australia, Poland