Renal Denervation in Patients With Refractory Hypertension

Overview

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

Interventions

  • Device: Renal Denervation

Arms, Groups and Cohorts

  • Experimental: Renal Denervation

Clinical Trial Outcome Measures

Primary Measures

  • Safety – complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
    • Time Frame: Through 3 years

Secondary Measures

  • Physiologic response to renal denervation (e.g., blood pressure reduction)
    • Time Frame: Through 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • Systolic blood pressure of 160 mmHg or greater – On 3 or more antihypertensive medications – eGFR >= 45 mL/min Exclusion Criteria:

  • Renal artery abnormalities – Known secondary hypertension attributable to a cause other than sleep apnea – MI, angina, CVA within 6 months – Type 1 diabetes – Others

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Vascular
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Henry Krum, PhD, Principal Investigator, Monash University and the Alfred Hospital

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