Age
Item
1. subject is at least 18 years of age and no more than 90 years of age
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure Average
Item
2. average sbp ≥ 160 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
24-hour ambulatory blood pressure monitoring Average | Systolic Pressure Daytime
Item
3. 24 hour average abpm daytime sbp ≥ 135 mmhg.
boolean
C2022220 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0332169 (UMLS CUI [2,2])
Change of medication Absent
Item
4. no medication changes for a minimum of 1 months prior to screening.
boolean
C0580105 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antihypertensive Agents Quantity | Diuretics Quantity | Dosage Criteria Fulfill
Item
5. at minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0178602 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
Dose Drug Labeled Highest
Item
1. highest labeled dose according to medication's labeling;
boolean
C0178602 (UMLS CUI [1,1])
C0013191 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Dose Usual Highest
Item
2. highest usual dose per clinical guidelines jnc-7;
boolean
C0178602 (UMLS CUI [1,1])
C3538928 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Maximum Tolerated Dose
Item
3. highest tolerated dose; and/or
boolean
C0752079 (UMLS CUI [1])
Dose Appropriate Highest
Item
4. highest appropriate dose for the subject per the pi's clinical judgment.
boolean
C0178602 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1522410 (UMLS CUI [1,3])
Kidney Functioning Quantity
Item
6. subject has two functioning kidneys.
boolean
C0022646 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Renal function GFR estimation by MDRD
Item
7. subject has an egfr value of ≥ 30 ml/min/1.73 m² (mdrd formula).
boolean
C2170215 (UMLS CUI [1])
Secondary hypertension
Item
1. subject has any secondary cause of hypertension
boolean
C0155616 (UMLS CUI [1])
Renal Artery Stenosis Flow Rate | Renal Artery Stenosis Arterial velocity | Renal Artery Stenosis Doppler ultrasonography of artery
Item
2. subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and doppler analysis on ultrasound
boolean
C0035067 (UMLS CUI [1,1])
C2826285 (UMLS CUI [1,2])
C0035067 (UMLS CUI [2,1])
C0429859 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3,1])
C2021508 (UMLS CUI [3,2])
Kidney Calculi Size Location | Kidney Calculi Interfere with Therapeutic procedure
Item
3. subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
boolean
C0022650 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0022650 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Operation on abdominal region
Item
4. subject has a history of intra-abdominal surgery within the past six months
boolean
C0198482 (UMLS CUI [1])
Kidney Heterogeneity Interferes with Therapeutic procedure | Cysts Large | Tumors Large
Item
5. subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
boolean
C0022646 (UMLS CUI [1,1])
C0019409 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0010709 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0027651 (UMLS CUI [3,1])
C0549177 (UMLS CUI [3,2])
Heart valve disease Stenotic | Blood Pressure Reduction At risk
Item
6. stenotic valvular heart disease for which bp reduction would be hazardous as determined by referring physician.
boolean
C0018824 (UMLS CUI [1,1])
C0333181 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2,1])
C1293152 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
7. mi, unstable angina, or cva in the prior 6 months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Primary pulmonary hypertension Severe
Item
8. known severe primary pulmonary htn
boolean
C0152171 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident
Item
9. subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Heart valve disease Hemodynamic Significant
Item
10. subject has hemodynamically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Body mass index
Item
11. subject has bmi over 40 km/m^2
boolean
C1305855 (UMLS CUI [1])
Targeted Therapy Depth
Item
12. subject has a target treatment depth over 13 cm.
boolean
C2985566 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Anatomy aspects Exclude Therapeutic procedure Specified | Other Coding
Item
13. subject has anatomy that precludes treatment with the kona medical surround sound system.
boolean
C1384516 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
C3846158 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
14. subject is pregnant, nursing, or intends to become pregnant during the trial period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status Interferes with Research
Item
15. subject is currently enrolled in other potentially confounding research.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0035168 (UMLS CUI [1,3])
Condition Study Subject Participation Status Excluded
Item
16. subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Clinical Study Follow-up Compliance Unable | Clinical Study Follow-up Compliance Unwilling
Item
17. subject is unable, or unwilling, to comply with the protocol-required follow-up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])