Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

Study Overview
=================
Brief Summary
-----------------
The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

Detailed Description
-----------------
This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures. Patient blood pressure will be measured by in the office according to recognized international techniques and standards. Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.

Official Title
-----------------
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Renal Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have provided written informed consent; Subjects who are ≥ 18 years and ≤ 75 years of age; Subjects who have Systolic Blood Pressure (SBP) ≥ 160 mm Hg based on an average of three (3) office-based blood pressure readings (seated) measured according to protocol; Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m^2; Suitable renal artery anatomy Subjects who are willing and able to comply with all study procedures. Exclusion Criteria: Subjects with known/diagnosed secondary hypertension; Subjects who are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure; Subjects with known bleeding or hyper-coagulation disorders; Subjects who have type 1 diabetes mellitus; Subjects who have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques; Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months; Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous; Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically significant abnormal electrocardiogram Subjects who have any serious medical condition, which in the opinion of the investigator, may adversely affect patient safety or the efficacy of the procedure in the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia); Subjects who are pregnant, nursing or planning to become pregnant; Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency; Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed; Subjects who, for any reason, may not be able to understand or comply with instructions; Subjects who are contraindicated for intravascular contrast material; Subjects who are currently taking estrogen or any estrogen-like compound. Subjects who have had a prior renal denervation procedure Subjects with prior intervention to right or left renal artery; Subjects with ≥ 30% renal artery stenosis Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure; Subjects in which the physician is unable to safely cannulate the renal artery; Subjects in which the physician is unable to percutaneously access the femoral artery; Subjects with one kidney.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Renal Denvervation<br>All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System. | Device: Renal Denervation<br>* percutaneous renal denervation using the Vessix RF balloon catheter<br>* Other names: Vessix V2 Renal Denervation System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment | Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. . | Baseline and 6 months | 
| Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure | Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Flow Limiting Stenosis in the Renal Artery | Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound | 6 months | 
| Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery |  | Duration of the procedure (average of 65 minutes) | 
| Renal Artery Infarction or Embolus |  | Duration of the procedure (average of 65 minutes) | 
| Cerebrovascular Accident (CVA) at Time of Procedure |  | Duration of the procedure (average of 65 minutes) | 
| Myocardial Infarction at Time of Procedure |  | Duration of the procedure (average of 65 minutes) | 
| Sudden Cardiac Death at Time of Procedure |  | Duration of the procedure (average of 65 minutes) | 
| Angiographically-documented Renal Stenosis Requiring an Intervention |  | 2 Years | 
| Chronic Symptomatic Orthostatic Hypotension |  | 2 Years | 
| Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance) |  | 2 Years | 
| Reduction in Estimated Glomerular Filtration Rate (eGFR) >25% |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension