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Renal Denervation in Patients With Refractory Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753285
First Posted: September 16, 2008
Last Update Posted: November 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Vascular
  Purpose
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.

Condition Intervention
Hypertension Device: Renal Denervation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Refractory Hypertension

Further study details as provided by Medtronic Vascular:

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

Enrollment: 35
Study Start Date: September 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Denervation Device: Renal Denervation
Other Name: Symplicity Renal Denervation System

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753285


Locations
United States, Illinois
Prairie Heart Institute
Springfield, Illinois, United States, 62701
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Henry Krum, PhD Monash University and the Alfred Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00753285     History of Changes
Other Study ID Numbers: TP-040
First Submitted: September 12, 2008
First Posted: September 16, 2008
Last Update Posted: November 10, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases