Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

Not Applicable

Completed

Brief Summary: This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.

Detailed Description: Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.

Safety Marker

* All adverse events

Efficacy Marker

* Office blood pressure

Recruitment & Eligibility

Inclusion Criteria

Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
Age ≥18 and ≤80 years old
Able and willing to provide written informed consent to participate in the study
Able and willing to comply with the required follow-up schedule

Exclusion Criteria

Prior renal artery intervention (balloon angioplasty or stenting)
Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
Multiple main renal arteries in either kidney
Main renal arteries <4 mm in diameter or <20 mm in length
eGFR of <45 mL/min per 1.73 m2 using the MDRD formula
Type 1 diabetes
Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
Others

Primary Outcome Measures

Name	Time	Method
Adverse Events	24 months	All device or procedure related adverse events
Office Systolic Blood Pressure Change	Baseline to 6 months

Secondary Outcome Measures

Name	Time	Method

Locations (4): Monash Medical Centre
🇦🇺
Melbourne, Victoria, Australia
Hippokration Hospital
🇬🇷
Athens, Greece
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
Flinders Medical Centre
🇦🇺
Adelaide, South Australia, Australia