Renal Artery Ablation, Resistant Hypertension, Uncontrolled Hypertension
Conditions
Keywords
Resistant hypertension, Uncontrolled hypertension, Renal artery ablation
Brief summary
This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.
Interventions
DEVICERenal Denervation (OneShot™ Renal Denervation System)
Sponsors
Medtronic Endovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings. * Stable drug regimen including three or more anti-hypertensive medications including a diuretic
Exclusion criteria
* Renal anatomy unsuitable for treatment * Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous * Patient has Type I diabetes * Has scheduled or planned surgery within the next 6 months * Individual is pregnant nursing or plans to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse event (MAE) rate through 30 days post randomization | 30 days |
| Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Acute Procedural Safety | 30 days |
| Chronic procedural safety | 6 months |
| Reduction in SBP by >10 mmHg at 6 months | 6 months |
| Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits | 6, 12, 24, and 36 months |
Countries
Italy
Outcome results
None listed