Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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 (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
Brief Summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.


Options:
A: Inclusion Criteria:

* Average SBP \>140mmHg, measured per guidelines
* 24 hour average ABPM daytime SBP \>135mm/Hg
* On stable medication regimen of full tolerated doses of 3 or more antihypertensive meds, with one being a diuretic
* No changes for a minimum of 2 weeks prior to screening
* No planned medication changes for 6 months
* Age 18-80 years
* At minimum, 3 antihypertensive medications must meet one or more of the following full dose criteria:
* Highest labeled dose according to medication's labeling
* Highest usual dose per clinical guidelines-JNC-7
* Highest tolerated dose
* Highest appropriate dose for the patient per the PI's clinical judgment

Exclusion Criteria:

* Hemodynamically or anatomically significant renal artery abnormalities or stenosis \>50% or prior renal artery intervention
* eGFR \< 45 mL/min/1.73m2 (MDRD formula)
* Albumin/creatinine ratio \> 50 mg/mmol
* Type 1 diabetes mellitus
* Known alcohol or drug abuse
* Symptomatic orthostatic hypotension in past year
* Stenotic valvular heart disease for which BP reduction would be hazardous
* MI, unstable angina, or CVA in the prior 6 months
* Known primary pulmonary HTN
* Known pheochromocytoma, Cushing's disease, coarctation of the aorta, hyperthyroidism or hyperparathyroidism
* Known primary hyperaldosteronism not adequately treated.
B: Inclusion Criteria:

* Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and \<180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
* Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and \< 170 mmHg.
* Individual is willing to discontinue current antihypertensive medications.

Exclusion Criteria:

* Individual lacks appropriate renal artery anatomy.
* Individual has estimated glomerular filtration rate (eGFR) of \<45.
* Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
* Individual has one or more episodes of orthostatic hypotension.
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to become pregnant.
* Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
* Individual has 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 at any time.
* Individual works night shifts.
C: Inclusion Criteria:

* Individual is ≥ 20 and ≤ 80 years old at time of randomization.
* 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 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
* 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
* Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria highlights:

* Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
* Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg
* Individual has type 1 diabetes mellitus
* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to be pregnant.
D: Inclusion Criteria:

* Symptomatic drug-refractory AF (with history of failure of ≥2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
* PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
* Office-based systolic blood pressure of ≥140/90 mm Hg, despite treatment with 3 antihypertensive drugs (including 1 diuretic)
* A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula

Exclusion Criteria:

* Secondary causes of hypertension
* Severe renal artery stenosis or dual renal arteries
* Congestive heart failure with NYHA II-IV symptoms
* Left ventricular ejection fraction \<35%
* Transverse left atrial diameter \> 60 mm on transthoracic echocardiography

  1. Previous AF ablation procedure
  2. Treatment with amiodarone
* Previous renal artery stenting or angioplasty
* Type 1 diabetes mellitus

Answer: B