Renal Denervation Using Externally Focused Therapeutic Ultrasound

Study Overview
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Brief Summary
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This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.

Detailed Description
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This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty patients who meet the eligibility criteria and have signed the informed consent form. Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.

Official Title
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A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: Surround Sound Externally Focused Therapeutic Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Average systolic blood pressure at least 160 mmHg Refractory, stable hypertension despite being treated with at least three hypertensive drugs Two functioning kidneys, defined as eGFR >= 45 ml/min At least one renal artery on each side which is greater than 4 mm. Exclusion Criteria: History of nephrectomy or hydronephrosis Renal stenosis > 50% Renal stent Ambulatory blood pressure monitoring 24 hour average systolic blood pressure <= 135 mmHg Kidney stones which are symptomatic and/or > 1 cm History of abdominal surgery within the past 6 months Heterogeneities in the kidneys (cysts or tumors) Residual pyelonephritis History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last 6 months Hemodynamically significant valvular heart disease Implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI Body weight > 150 kilograms Target treatment depth > 14 cm from the skin line Pregnant, nursing or intends to become pregnant during the trial period

Ages Eligible for Study
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Minimum Age: 18 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 Denervation<br>Renal Denervation using the Kona Surround Sound Externally Focused Therapeutic Ultrasound therapy. | Device: Surround Sound Externally Focused Therapeutic Ultrasound<br>* Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through 52-week evaluation. Included in this assessment will be the proportion of subjects with any of the following outcomes: 1) death, or 2) medical morbidity. | 52-week post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Utility | Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure. | 52-week post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension