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

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

Detailed Description
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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

Official Title
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Ablation-induced Renal Sympathetic Denervation Trial

Conditions
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Hypertension

Intervention / Treatment
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* Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal artery ablation<br>Catheter-based RF ablation in renal artery | Device: St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)<br>* Catheter-based RF ablation in renal artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | All device or procedure related adverse events | 24 months | 
| Office Systolic Blood Pressure Change |  | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter-based renal artery ablation, Hypertension, Resistant to Conventional Therapy