HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure

Study Overview
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Brief Summary
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To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension

Official Title
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High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure

Conditions
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Hypertension

Intervention / Treatment
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* Device: Renal denervation guided by HFS
* Device: Renal denervation as standard procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic). A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula. Exclusion Criteria: Secondary causes of hypertension Severe renal artery stenosis or dual renal arteries Congestive heart failure Left ventricular ejection fraction <35% Previous renal artery stenting or angioplasty Type 1 diabetes mellitus

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (RDN guided by HFS)<br>Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. | Device: Renal denervation guided by HFS<br> <br> |
| Active Comparator: Group 2 (RDN as standard procedure)<br>Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP | Device: Renal denervation as standard procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of responders to renal denervation procedure |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications rate |  | 12 month | 
| cross-over rate |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal denervation, Ablation