Renal Denervation for Treatment of Resistant Hypertension in Patients With Chronic Kidney Disease

This is an expanded access trial for Hypertension focused on measuring Treatment-resistant Hypertension, Chronic Kidney Disease, Symplicity catheters, Renal denervation Read More

Inclusion Criteria:

1. Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics).
2. Individual is adhering to a stable drug regimen including 3 or more anti-hypertensive medications, of which one is a diuretic, (with no changes for a minimum of 2 weeks prior to enrollment) and is expected to be maintained for at least 6 months.
3. Individual with stage 3 chronic kidney disease, defined as having an eGFR of 30 - 60 mL/min/1.73m2, using the MDRD calculation.
4. Individual is ≥ 21 and ≤ 65 years of age.
5. 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:

1. Individual has renal artery anatomy that is ineligible for treatment including:

   1. Main renal arteries < 4 mm in diameter or < 20 mm in length.
   2. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation.
   3. A history of prior renal artery intervention including balloon angioplasty or stenting.
   4. Multiple main renal arteries in either kidney.
2. Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation.
3. Individual has type 1 diabetes mellitus.
4. Individual has experienced a myocardial infarction, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
5. Individual has a scheduled or planned surgery or cardiovascular intervention in the next 6 months.
6. Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
7. Individual has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI).
8. Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
9. Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.]
10. Individual is currently enrolled in another investigational drug or device trial.