Renal Denervation in Patients With Refractory Hypertension (HTN-1)

Medtronic

Status: Completed

Conditions: Hypertension

Treatments: Device: Symplicty(TM) Catheter System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664638

TP-037

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)