Chronic kidney disease (or) chronic renal disease high blood pressure Hypertension
Conditions
Sponsors
Ardian, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: . Individual has a systolic blood pressure higher than 160 mmHg (higher than 150 mmHg for type 2 diabetics). 2. Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months. 3. Individual is >=18 and
Exclusion criteria
Exclusion criteria: . Individual has anatomically abnormal renal artery (this is defined in detail in the study protocol on page 13). 2. Individual has an estimated glomerular filtration rate (eGFR) of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| To document the physiologic effects of denervation in patients with refractory hypertension. To determine whether renal denervation contributes to hypertension control. To determine whether renal denervation improves renal function To determine whether renal denervation contributes to improvement of glucose management in patients with abnormal baseline Hemoglobin A1c To assess the performance of the Ardian Symplicity Catheter System | — |
Countries
Netherlands
Outcome results
None listed