Evaluation of the Integrated Radio Frequency Denervation System for the Treatment of Hypertension

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety of renal denervation using the iRF System and to understand any potential improvement in hypertension.

Detailed Description
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This study is a prospective, single-arm, multi-center, non-randomized trial to evaluate the initial safety and performance of renal denervation with the iRF system for the treatment of hypertension.

Official Title
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A Renal Artery Denervation Feasibility Study of the MetAvention Integrated Radio Frequency Denervation System for the Treatment of Hypertension

Conditions
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Hypertension, Metabolic Syndrome

Intervention / Treatment
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* Device: iRF System Renal Denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 80 years old Office SBP ≥ 140 and < 180 mmHg on a stable dose of antihypertensive medication(s) for at least 30 days Documented daytime systolic ABP ≥ 135 and < 170 mmHg Waist circumference ≥ 102 cm (male) and ≥ 88 cm (female) Exclusion Criteria: Renal artery anatomy on either side, ineligible for treatment including the following: Main renal artery diameter < 4.0 mm or > 7.0 mm Main renal artery length < 20.0 mm Only one functioning kidney Presence of abnormal kidney tumors Renal artery with aneurysm Pre-existing renal stent or history of renal artery angioplasty Fibromuscular disease of the renal arteries Presence of renal artery stenosis of any origin ≥ 30 % Individual lacks appropriate renal artery anatomy Prior renal denervation procedure Iliac/femoral artery stenosis precluding insertion of the iRF Catheter Evidence of active infection within 7 days of the Index Procedure Type 1 diabetes mellitus Documented history of chronic active inflammatory bowel disorders such as Crohn disease or ulcerative colitis eGFR < 45 mL/min per 1.73 m2 Brachial circumference ≥ 42 cm Any history of cerebrovascular event (e.g., stroke, transient ischemic event, and cerebrovascular accident) within 6 months of patient consent Myocardial infarction within 6 months of patient consent Heart failure (New York Heart Association [NYHA] Class III-IV) at time of consent Documented confirmed episode(s) of stable or unstable angina within 6 months of patient consent Documented history of persistent or permanent atrial tachyarrhythmia Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea Night shift workers Chronic regular use (e.g., daily use) of NSAIDs for 6 months or greater. Aspirin therapy is allowed. Active implantable medical device (e.g., ICD or CRT-D, neuromodulator/spinal stimulator, baroreflex stimulator) Primary pulmonary HTN (> 60 mmHg pulmonary artery or right ventricular systolic pressure) Individual has known pheochromocytoma, Cushing syndrome, primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism. (Note: Treated hyperthyroidism and treated hypothyroidism are permissible.) Documented contraindication or allergy to contrast medium not amenable to treatment Limited life expectancy of < 1 year at the discretion of the investigator Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g., night shift workers) Pregnant, nursing, or planning to become pregnant (documented negative pregnancy test result required documented within a maximum of 7 days before procedure for all women of childbearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in noninterventional registries is acceptable)

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: The study is a prospective, single-arm, multi-center, non-randomized feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br>Renal denervation with the iRF system | Device: iRF System Renal Denervation<br>* The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Major Adverse Events | Incidence of the following Major Adverse Events (MAEs) Death (all-cause) New onset end stage renal disease Significant embolic events resulting in end-organ damage Renal artery perforation or dissection requiring intervention Hospital admission for hypertensive crisis not related to confirmed non-adherence with medications or protocol New renal stenosis > 70 % | Index Procedure through 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic/Diastolic Blood Pressure - Average Automated Office Blood Pressure | Change from baseline in systolic/diastolic blood pressure as indicated by average automated office blood pressure | Time Frame: 30, 90, 180 and 365 days | 
| Change in Systolic/Diastolic Blood Pressure - Ambulatory Blood Pressure Monitoring | Change from baseline in systolic/diastolic blood pressure as indicated by ambulatory blood pressure monitoring | Time Frame: 90, 180 and 365 days | 
| Effects on renal function assessed with glomerular filtration rate | Change from baseline in renal function as indicated by eGFR | Time Frame: 30, 90, 180 and 365 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Denervation