Status:
COMPLETED
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01438229
Start Date
October 1 2011
End Date
July 1 2014
Last Update
February 5 2019
Active Locations (4)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
3
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
4
Hippokration Hospital
Athens, Greece