Renal Denervation in Patients With Refractory Hypertension (HTN-1)
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To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. [ Time Frame: 3 years ]
Secondary Outcome Measures :
To document the physiologic effects of renal denervation in patients with refractory hypertension. [ Time Frame: 3 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
>= 18 years of age
a systolic blood pressure of 160mmHg or more
receiving and adhering to full doses of at least three antihypertensive drugs
estimated glomerular filtration rate (eGFR) of ≥45mL/min
agrees to have the study procedure(s) performed and additional procedures and evaluations
is competent and willing to provide written, informed consent to participate in this clinical study
hemodynamically or anatomically significant renal artery stenosis
has a history or prior renal artery angioplasty
has experienced MI, unstable angina pectoris, or CVA within 6 months
has hemodynamically significant valvular heart disease
has Type 1 diabetes
has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
requires respiratory support
is pregnant, nursing, or planning to be pregnant
has known, unresolved history of drug use or alcohol dependency.
is currently enrolled in another investigational drug or device trial.