Status:
COMPLETED
Renal Denervation in Patients With Refractory Hypertension
Lead Sponsor:
Medtronic Vascular
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
Eligibility Criteria
Inclusion
- \>= 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00664638
Start Date
April 1 2008
End Date
May 1 2013
Last Update
November 5 2013
Active Locations (9)
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1
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
2
St. Elisabeth Hospital
Bochum, Germany
3
Klinikum Coburg
Coburg, Germany
4
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany