Hypertension
Conditions
Brief summary
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
Interventions
DEVICEArdian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 18 years of age. * a systolic blood pressure of 160 mmHg or greater. * receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening. * agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination. * competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion criteria
* renal arterial abnormalities * end stage renal disease requiring dialysis or renal transplant * serum Cr \> 3, or calculated GFR \< 45 ml/min * has experienced MI, unstable angina pectoris, or CVA with 6 months * others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide confirmation that renal denervation is safe and feasible. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Evidence of renal denervation; indication of physiologic response; assessment of device performance. | 3 years |
Countries
Australia, Poland
Outcome results
None listed