Hypertension
Conditions
Keywords
RDN
Brief summary
To evaluate the safety and performance of the ConfidenHT System
Detailed description
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
Interventions
DEVICEConfidenHT system
ConfidenHT Medical system
Sponsors
BlueWind Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
1. Previous participation in another study with any investigational drug or device within the past 30 days. 2. Relevant renal artery disease (% diameter stenosis\>30%, aneurysm or fibromuscular dysplasia). 3. Known secondary causes of hypertension. 4. The patient has a life expectancy ≤ 12 months. 5. The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts. 6. The patient has chronic oxygen use other than nocturnal support for sleep apnea. 7. The patient has type I diabetes mellitus. 8. The patient has had a previous organ transplant or is awaiting a renal transplant. 9. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator). 10. The patient has triple ipsilateral artery ostia. 11. Moderate to severe valvular heart disease. 12. The patient has other concomitant conditions that may adversely affect the patient or the study outcome. 13. Female who is pregnant, nursing or planning to become pregnant. 14. Documented contraindication or allergy to contrast medium not amenable to treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of serious adverse events (system and/or procedure related events) | 3 months | The incidence of serious adverse events (system and/or procedure related events) |
Countries
Greece, Netherlands
Outcome results
None listed