Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension

A Clinical Trial for the Assessment of Safety and Efficacy of the UltraSOUND Mediated InTerVentional Treatment of Resistant Hypertension

The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.

Inclusion Criteria:

• Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
• Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
• Renal artery diameter ≥5mm by digital angiography
• Accessibility of renal vasculature

Exclusion Criteria:

• Estimated GFR < 45
• Type 1 Diabetes
• Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)