Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

Study Overview
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Brief Summary
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The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy

Detailed Description
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The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Official Title
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The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Device: MDT-2211 Renal Denervation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual is ≥ 20 and ≤ 80 years old at time of randomization. Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months. Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study. Exclusion Criteria highlights: Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg Individual has type 1 diabetes mellitus Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea. Individual has primary pulmonary hypertension. Individual is pregnant, nursing or planning to be pregnant.

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation<br>Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications. | Device: MDT-2211 Renal Denervation System<br>* A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.<br>|
| No Intervention: Control Group<br>Subjects are maintained on baseline anti-hypertensive medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Systolic Blood Pressure |  | Baseline to 6 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Adverse Events (MAE) |  | Baseline through 1 month post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal denervation