Hypertension
Conditions
Brief summary
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.
Interventions
DEVICERenal Denervation
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Systolic blood pressure of 160 mmHg or greater * On 3 or more antihypertensive medications * eGFR \>= 45 mL/min
Exclusion criteria
* Renal artery abnormalities * Known secondary hypertension attributable to a cause other than sleep apnea * MI, angina, CVA within 6 months * Type 1 diabetes * Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. | Through 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Physiologic response to renal denervation (e.g., blood pressure reduction) | Through 3 years |
Countries
United States
Outcome results
None listed