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Status: Withdrawn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: 34

Inclusion Criteria

1. Individual is * 20 and * 80 years old at time of enrollment (consent).
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.
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.
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 one or more of the following conditions: stable or unstable angina within 3
months of enrollment, myocardial infarction within 3 months of enrollment, heart failure,
cerebrovascular accident or transient ischemic attack, or atrial fibrillation. Patients are
permitted to take aspirin or clopidogrel for cardiovascular risk reduction.
2. Individual has undergone prior renal denervation
3. Individual has renal artery anatomy that is ineligible for treatment including:
a. Presence of FMD (defined as visible beading of the artery on angiography)
b. Lacks a main renal arterial vessel (greater than 3mm and less than 8mm in
diameter) for each kidney that:
*. Does not allow 4 simultaneous quadrantic (4SQ) radio frequency ablations in the main renal artery or equivalent (defined as 4SQ ablations in all branch vessels greater than 3mm and less than 8mm)
* Has >50% stenosis
* Has a renal artery stent placed <3 months prior to the denervation
procedure
4. Treatment within 5mm of a segment in the renal artery which contains any of the following:
a. Atheroma,
b. Calcification,
c. Aneurysm, or
d. Renal artery stent
5. Individual has an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2, using
the 4 variable MDRD calculation (in mL/min per 1.73 m2 = 175 x SerumCr-1.154 x age-0.203 x
1.212 (if patient is black) x 0.742 (if female). (NOTE: an eGFR calculation specific to
Japanese patients will be used for subjects enrolled in Japan)
6. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes
mellitus with glycosylated hemoglobin greater than 8.0% or is taking SGLT2 inhibitors or
GLP-1 agonists.
7. Individual has had *1 episode(s) of orthostatic hypotension not related to medication
changes within the past year or reduction of SBP of *20 mmHg or DBP of *10 mmHg within
3 minutes of standing coupled with symptoms during the screening process.
8. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal
respiratory support for sleep apnea (e.g. CPAP, BiPAP).
9. Individual is being treated chronically (e.g. daily use) with non-steroidal anti-inflammatory
drugs (NSAIDs). Aspirin therapy is allowed.
10. Individual has documented primary pulmonary hypertension.
11. Individual has known pheochromocytoma, Cushing*s Syndrome (hypercortisolism), primary
hyperaldosteronism coarctation of the aorta, untreated hyperthroidism, untreated
hypothyroidism, or primary hyperparathyroidism. (Note: treated hyperthyroidism and treated
hyperthyroidism are permissible).
12. Individual has a scheduled or planned surgery that, in the opinion of the Investigator, may
affect study endpoints.
13. 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).
14. Individual works night shifts.
15. Individual has severe cardiac valve stenosis for which, in the opinion of the investigator, a
significant reduction of blood pressure is contraindicated.
16. Individual has a documented confounding me