Hypertension
Conditions
Brief summary
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
Interventions
DEVICESymplicty(TM) Catheter System
Renal denervation using the Symplicity Catheter System
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| To document the physiologic effects of renal denervation in patients with refractory hypertension. | 3 years |
Countries
Germany
Outcome results
None listed