Renal Denervation in Patients with Uncontrolled Hypertension (HTN-3) (Protocol IP125)
This prospective, randomized, blinded, controlled study is needed to confirm the value of this alternative for this
population of patients who are failing existing treatment and remain at increased cardiovascular risk. This study is [Double Quote]Randomized[Double Quote] meaning that patients who are confirmed to be eligible will be randomly assigned to one of the two groups. Each patient has a 2 to 1 chance of being assigned to the treatment group. This means you are twice as likely to be in the treatment group rather than the control group). The study is [Double Quote]Controlled[Double Quote] meaning two-thirds of the patients will be treated with the device (the [Double Quote]Treatment Group[Double Quote]) and one-third will NOT be treated with the device (the [Double Quote]Control Group[Double Quote]), and the results of the two groups will be compared. This study is also [Double Quote]Blinded[Double Quote] meaning that patients will not be told which group they are assigned to, and certain procedures will be followed to prevent patients from knowing which group they are in. This study design is necessary to properly evaluate the safety and effectiveness of the investigational device and procedure.
1. Individual is >or equal to 18 and ≤ 80 years old at time of randomization.
2. 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 2 weeks prior to screening) that is
expected to be maintained without changes for at least 6 months.
3. 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 (BP measures according to the guidelines in Appendix A).
4. Individual agrees to have all study procedures performed, and is competent and willing
to provide written, informed consent to participate in this clinical study.