Uncontrolled Hypertension
Conditions
Brief summary
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.
Interventions
DEVICEMedtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Individual is ≥ 18 and ≤ 80 years old. * Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings * Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.
Exclusion criteria
* Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2 * Individual has type 1 diabetes mellitus * Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea. * Individual has primary pulmonary hypertension. * Individual is pregnant, nursing or planning to be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute safety as measured by procedural complications | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Change in Office Systolic Blood Pressure | Baseline to 6 months |
Countries
Australia, New Zealand
Outcome results
None listed