Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BlueWind Medical
To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Signed written informed consent.
2. Age \>18 years and \<75.
3. Either:
1. Hypertensive patients planned to undergo elective cardiac catheterization
2. Potential candidates for renal sympathetic denervation
4. Main renal artery with diameter ≥ 4.0mm.
5. Glomerular Filtration Rate (GFR) \>45 mL/min
6. A patient who is mentally competent with the ability to understand and comply with the requirements of the study.
7. The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
8. Female patients with childbearing potential must agree:
* to use a valid method of contraception (oral contraceptives, intrauterine device, subcutaneous contraceptive implant, vaginal ring)
* to perform a pregnancy test
You may not be if
1. Previous participation in another study with any investigational drug or device within the past 30 days.
