Renal Denervation in Patients With Refractory Hypertension

Medtronic Vascular9 sites in 1 country45 target enrollmentApril 2008

ConditionsHypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: Medtronic Vascular
Enrollment: 45
Locations: 9
Primary Endpoint: 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.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

May 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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