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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