Age
Item
1. be at least 21 years of age.
boolean
C0001779 (UMLS CUI [1])
Carotid bifurcation Bilateral C3 C4
Item
2. have been assessed to have bilateral carotid bifurcations located at or below c3-c4.
boolean
C0447037 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0223116 (UMLS CUI [1,3])
C0223131 (UMLS CUI [1,4])
Systolic Pressure Cuff | Blood pressure ambulatory Systolic 24 Hours | Antihypertensive Agents Quantity | Diuretic Quantity
Item
3. have an office cuff systolic blood pressure greater than or equal to 160 mmhg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmhg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
boolean
C0871470 (UMLS CUI [1,1])
C0441107 (UMLS CUI [1,2])
C0855316 (UMLS CUI [2,1])
C0039155 (UMLS CUI [2,2])
C1442770 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Compliance behavior | Intake Pharmaceutical Preparations Dosage Full
Item
4. must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
boolean
C1321605 (UMLS CUI [1])
C1512806 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0443225 (UMLS CUI [2,4])
Informed Consent
Item
5. have signed a cvrx approved informed consent for participation in this study.
boolean
C0021430 (UMLS CUI [1])
Diagnosed
Item
1. have been diagnosed with:
boolean
C0011900 (UMLS CUI [1])
Baroreflex failure
Item
baroreflex failure
boolean
C1959798 (UMLS CUI [1])
Bradyarrhythmia cardiac
Item
cardiac bradyarrhythmias
boolean
C0079035 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Chronic atrial fibrillation
Item
chronic atrial fibrillation
boolean
C0694539 (UMLS CUI [1])
Heart Transplantation
Item
2. had a heart transplant
boolean
C0018823 (UMLS CUI [1])
Carotid Atherosclerosis | Diameter Linear Percentage Reduction | Ultrasonics | Angiography
Item
3. have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
boolean
C0577631 (UMLS CUI [1])
C1301886 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0392756 (UMLS CUI [2,4])
C1456803 (UMLS CUI [3])
C0002978 (UMLS CUI [4])
Ulcerative lesions Grade Carotid Artery Ultrasonics | Ulcerative lesions Grade Carotid Artery Angiography
Item
4. have grade c ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
boolean
C0041582 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0007272 (UMLS CUI [1,3])
C1456803 (UMLS CUI [1,4])
C0041582 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0007272 (UMLS CUI [2,3])
C0002978 (UMLS CUI [2,4])
Operative Surgical Procedure Carotid sinus Region Either | Therapeutic radiology procedure Carotid sinus Region Either
Item
5. have prior surgery or radiation in either carotid sinus region.
boolean
C0543467 (UMLS CUI [1,1])
C0007281 (UMLS CUI [1,2])
C0205147 (UMLS CUI [1,3])
C3844638 (UMLS CUI [1,4])
C1522449 (UMLS CUI [2,1])
C0007281 (UMLS CUI [2,2])
C0205147 (UMLS CUI [2,3])
C3844638 (UMLS CUI [2,4])
Implanted Medical Device Electrical | Cardiac pacing | Electric Countershock | Neurostimulation
Item
6. currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
boolean
C2828363 (UMLS CUI [1,1])
C0442828 (UMLS CUI [1,2])
C0199640 (UMLS CUI [2])
C0013778 (UMLS CUI [3])
C0521307 (UMLS CUI [4])
Pregnancy | Pregnancy, Planned
Item
7. are pregnant or contemplating pregnancy during the 13-month follow-up period.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Dialysis
Item
8. currently undergoing dialysis.
boolean
C0011946 (UMLS CUI [1])
Hypertensive disease Cause Secondary to
Item
9. have hypertension secondary to a treatable cause.
boolean
C0020538 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
Heart valve disease
Item
10. have clinically significant cardiac valvular disease.
boolean
C0018824 (UMLS CUI [1])
Protocol Compliance Unwilling | Follow-up Requirement Unwilling
Item
11. are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Follow-up Survival Unlikely
Item
12. are unlikely to survive the protocol follow-up period.
boolean
C3274571 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Study Subject Participation Status
Item
13. are enrolled in another concurrent clinical trial.
boolean
C2348568 (UMLS CUI [1])