Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

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

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.

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.

Inclusion Criteria:

1. Subjects who have provided written informed consent;
2. Subjects who are ≥ 18 years and ≤ 75 years of age;
3. 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;
4. Subjects with ≥ 3 anti-hypertensive drugs at maximally tolerated doses with stable regimen for at least 2 weeks prior to enrollment
5. Subjects with a estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m^2;
6. Suitable renal artery anatomy
7. Subjects who are willing and able to comply with all study procedures.

Exclusion Criteria:

1. Subjects with known/diagnosed secondary hypertension;
2. 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;
3. Subjects with known bleeding or hyper-coagulation disorders;
4. Subjects who have type 1 diabetes mellitus;
5. 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;
6. Subjects who have planned percutaneous vascular or surgical intervention for any reason within the next 6 months;
7. Subjects who have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous;
8. Subjects who have an implantable cardioverter defibrillator, pacemaker, or clinically significant abnormal electrocardiogram
9. 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);
10. Subjects who are pregnant, nursing or planning to become pregnant;
11. Subjects who have a known, unresolved history of drug use or alcohol abuse/dependency;
12. Subjects who are currently enrolled in any investigational study wherein patient participation has not been completed;
13. Subjects who, for any reason, may not be able to understand or comply with instructions;
14. Subjects who are contraindicated for intravascular contrast material;
15. Subjects who are currently taking estrogen or any estrogen-like compound.
16. Subjects who have had a prior renal denervation procedure
17. Subjects with prior intervention to right or left renal artery;
18. Subjects with ≥ 30% renal artery stenosis
19. Subjects with severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure;
20. Subjects in which the physician is unable to safely cannulate the renal artery;
21. Subjects in which the physician is unable to percutaneously access the femoral artery;
22. Subjects with one kidney.