Rapid Renal Sympathetic Denervation for Resistant Hypertension

Study Overview
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Brief Summary
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The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Detailed Description
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Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user variance inherent in the currently available point-by-point approach. In addition, technological improvements have been incorporated. The OneShot™ RF generator has a touchscreen, user friendly interface; catheter advancement is made safer with the use of a guidewire; two radiopaque markers on the catheter enable more precise device positioning; and the irrigated catheter tip reduces the risk of overheating and clot formation during RF delivery. By offering a more reliable single treatment approach, coupled with enhanced ease-of use and reduced procedure times, this technology has the potential to significantly expand clinical adoption of catheter-based renal sympathetic denervation.

Official Title
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Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System

Conditions
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Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
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* Device: Covidien OneShot™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening. Age 18-85 years. Able to provide informed consent and comply with follow-up visits. Exclusion Criteria: Diameter of left or right renal artery less than 4 mm or greater than 7mm. Length of target segment of left or right renal artery less than 20mm. Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty. End-stage renal disease requiring dialysis or renal transplant. estimated Glomerular Filtration Rate < 45 mL/min per 1.73 m2. Type 1 diabetes mellitus. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous. Bleeding disorder or refusing blood transfusions. Pregnancy or breast feeding. Peripheral vascular disease precluding catheter insertion. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study. Current enrollment in another investigational drug or device Study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Rapid Renal Denervation<br> | Device: Covidien OneShot™ System<br>* Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.<br>* Other names: Covidien OneShot™ Renal Denervation System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Safety | Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge: SAE's related to groin and vascular access complications, and SAE's related to renal artery injury. | One Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Procedural Safety | Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months | 6 months | 
| Renal Denervation Procedure Effectiveness | Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline | From baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Kidney Diseases, Kidney Failure, Chronic, Vascular Diseases, Cardiovascular Diseases, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency