Full Length Versus Proximal Renal Arteries Ablation

Study Overview
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Brief Summary
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Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.

Detailed Description
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After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.

Official Title
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The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

Conditions
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Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
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* Device: Thermocool®Rcatheter
* Device: Thermocool®Rcatheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: office systolic blood pressure of 160 mm Hg or more, patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment. Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications; ≥ 18 years old,; did not have any known secondary cause of hypertension; had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more. Exclusion Criteria: patients with type 1 diabetes, implanted pacemakers or implantable cardioverter defibrillators; pregnant women; haemodynamically significant valvular disease; patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Group 1 received ablation from distal to ostial of bilateral renal arteries | Device: Thermocool®Rcatheter<br>* The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter<br>|
| Experimental: Group 2<br>group 2 received ablation at proximal of bilateral renal arteries | Device: Thermocool®Rcatheter<br>* The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | office BP and Ambulatory blood pressure | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ablation-related complications | ablation-related complications such as pseudoaneurysm，renal artery injury | one year |