A Study to Evaluate Safety and Efficacy of the Redy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

Study Overview
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Brief Summary
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The ReDy™ System (Renal Dynamics) is a renal denervation device incorporating a variety of ablation features and technical improvements over previously designed systems into a single product. It is intended to treat uncontrolled (drug-resistant) hypertension by RF ablation of the sympathetic nerve network surrounding the renal arteries. This study will be carried out to validate the safety and the efficacy of the ReDy™ Renal Denervation device and to demonstrate that it performs according to its intended use, i.e. the treatment of patients with uncontrolled hypertension.

Official Title
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A Prospective, Post-marketing, Single-arm, Open Label, Multi-center Clinical Study to Evaluate the Safety and Efficacy of the ReDy™ Renal Denervation System in the Treatment of Patients With Uncontrolled Hypertension

Conditions
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Hypertension Resistant to Conventional Therapy

Intervention / Treatment
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* Device: Redy™ Renal Denervation System


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient has established hypertension (diagnosed ≥12 months prior to screening) and is on a guideline based stable drug regimen (≥ 4 weeks), consisting of ≥3 anti-hypertensive medications of different classes including a diuretic; Office systolic blood pressure >150 mmHg; Patient has (under directly observed therapy) average daytime systolic blood pressure values > 140 mmHg by 24h ambulatory blood pressure monitoring; Patient is ≥ 18 and ≤ 75 years of age at time of consent; Patient must be able and willing to comply with the required follow-up schedule; Patient must be able and willing to provide written informed consent; Exclusion criteria: Patient has known significant reno-vascular abnormalities such as renal artery stenosis > 30%; Patient has Isolated Systolic Hypertension with a diastolic blood pressure < 90 mmHg; Evidence or history of secondary hypertension, other than sleep apnea syndrome; Patient has a history of prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent graft placement; Patient has significant valvular heart disease; Patient has known coagulation abnormalities; Patient life expectancy is < 12 months, as estimated by the study Investigator; Patient is participating in another clinical study, which is before its primary endpoint and/or has the potential to impact his/her hypertension management (pharmaceutical / device); Patient is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods; Patient has active systemic infection; Patient has small <4.0 mm in diameter, large >6.5 mm in diameter or short <20.0 mm in length, multiple main, or highly tortuous renal arteries; Patient has impaired renal function with an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula; Patient had a renal transplant or is awaiting a renal transplant; Patient has a known intolerance for x-ray contrast agent that cannot be adequately controlled with pre-medication; Any medical condition as estimated by the Study Investigator that may harm patient or jeopardize study participation, the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition);

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Redy™ Renal Denervation System<br>Renal Denervation System | Device: Redy™ Renal Denervation System<br>* Renal Denervation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related adverse events at 1-month follow-up post treatment | Incidence of device-related Adverse Events at 1-month follow-up post treatment | 1-month post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-procedural Adverse Events at 1-month follow-up post treatment | Incidence of peri-procedural Adverse Events at 1-month follow-up post treatment | 1-month post treatment | 
| Device-related Adverse Events at 3 and 6 months follow-up post treatment | Incidence of device-related Adverse Events at 3 and 6 months follow-up post treatment | 3 and 6 months post treatment | 
| Reduction of average systolic daytime blood pressure assessed by 24h ABPM at 3-months | Reduction of average systolic daytime blood pressure as assessed by 24h ambulatory blood pressure monitoring at 3-month compared to baseline | 3 months post treatment | 
| Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment | Reduction of office systolic blood pressure at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment | 
| Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment | Reduction of office diastolic blood pressure at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment | 
| Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment | Blood pressure control to guideline recommended target blood pressure values at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled Hypertension, Resistant Hypertension, Renal Denervation