The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
St Andrews Hospital
Adelaide, South Australia, Australia
St. Vincent's Hospital Melbourne
Fizroy, Victoria, Australia
Monash Heart/Southern Health
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Safety Objective
To characterize the rate of serious procedural and device related adverse events from date of procedure through 6 months post procedure, as adjudicated by the Clinical Events Committee (CEC).
Time frame: 6 months
Performance objective
To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline.
Time frame: 6 months
Change in Ambulatory Blood Pressure
Characterization of the change in Ambulatory Blood Pressure parameters over time as compared to baseline
Time frame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
New renal artery stenosis or aneurysm at the site of ablation
Characterization of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation over time as compared to baseline
Time frame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Renal Function Change
Characterization of renal function change over time as compared to baseline as measured by changes in: eGFR, serum creatinine and cystatin C
Time frame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
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Auckland City Hospital
Auckland, New Zealand
Dunedin Hospital
Dunedin, New Zealand