Global Clinical Study of Renal Denervation with the Symplicity Spyral* multi-electrode renal denervation system in Patients with Uncontrolled Hypertension in the Absence of Antihypertensive Medications

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

1. Individual is * 20 and * 80 years old at time of randomization.
2. Individual has an office systolic blood pressure (SBP) * 150 mmHg and <180 mmHg and an office DBP *90 mmHg measured at Screening Visit 2, according to the guidelines in Appendix L.7 of the protocol.
3. Individual has a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP *140 mmHg and <170 mmHg measured at Screening Visit 2 according to guidelines in Appendix L.7 of the protocol.
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.
5. Individual is willing to discontinue current antihypertensive medications at Screening Visit 1 through the three month post-procedure visit.

Exclusion Criteria

1. Individual has undergone prior renal denervation.
2. Individual has renal artery anatomy that is ineligible for treatment including:
a. Lacks at least one renal arterial vessel for each kidney greater than 3 mm and less than 8 mm in diameter (including accessory, branch, and main renal arteries)
b. Main renal artery which contains renal artery stenosis (>50%), renal artery aneurysm, fibromuscular dysplasia (FMD), presence of a renal artery stent or calcification which does not allow at least four radio frequency ablations to be delivered in areas free of these abnormalities. FMD is defined as visible beading of the artery on angiography.
c. Unilateral kidney.
3. Individual has an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2, using the MDRD calculation. (Note: an eGFR calculation specific to Japanese patients will be used for subjects enrolled in Japan)
4. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%.
5. Individual has had *1 episode(s) of orthostatic hypotension not related to medication changes within the past year or has a reduction of SBP of *20 mmHg or DBP of *10 mmHg within 3 minutes of standing coupled with symptoms during the screening process.
6. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g. CPAP, BiPAP).
7. Individual is being treated chronically (e.g. daily use) with non-steroidal anti-inflammatory drugs (NSAIDs). Aspirin therapy is allowed.
8. Individual has documented primary pulmonary hypertension.
9. Individual has known pheochromocytoma, Cushing*s Disease (adrenal insufficiency), coarctation of the aorta, untreated hyper- or hypothyroidism, or primary hyperparathyroidism. (Note: treated hyperthyroidism and treated hypothyroidism are permissible).
10. Individual has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
11. Individual has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
12. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement using the protocol-specified automatic blood pressure monitor (e.g., upper arm circumference outside cuff size ranges available by geography or arrhythmia that interferes with automatic monitor*s pulse sensing and prohibits an accurate measurement).
13. Individual works night shifts.
14. Individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a significant reduction of blood pressure is contraindicated.
15. Individual has a documented confounding medical condition, which in the opinion of the investigator, may adversely affect the safety of the participant (e.g., patients with clinically significant peripheral vascular disease, aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
16. Individual is pregnant, nursing or planning to become pregnant during the course of the study follow-up. (Note: Pre-menopausal female participants must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test