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Renal Denervation in Patients With Refractory Hypertension

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. Identifier: NCT00483808
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):
Medtronic Vascular

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

Condition or disease Intervention/treatment Phase
Hypertension Device: Ardian Symplicity™ Catheter Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Renal Denervation in Patients With Refractory Hypertension
Study Start Date : June 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Denervation
Renal denervation using the Symplicty Catheter
Device: Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter

Primary Outcome Measures :
  1. To provide confirmation that renal denervation is safe and feasible. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Evidence of renal denervation; indication of physiologic response; assessment of device performance. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • >= 18 years of age.
  • a systolic blood pressure of 160 mmHg or greater.
  • receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
  • agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
  • competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

  • renal arterial abnormalities
  • end stage renal disease requiring dialysis or renal transplant
  • serum Cr > 3, or calculated GFR < 45 ml/min
  • has experienced MI, unstable angina pectoris, or CVA with 6 months
  • others

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 identifier (NCT number): NCT00483808

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Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
John Paul II Hospital
Krakow, Poland
Sponsors and Collaborators
Medtronic Vascular
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Principal Investigator: Henry Krum, MBBS,PhD The Alfred Hospital and Monash University, Melbourne, VIC, Australia
Principal Investigator: Robert Whitbourn, MBBS, FRACP St. Vincent's Hospital, Fitzroy, VIC, Australia
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Medtronic Vascular Identifier: NCT00483808    
Other Study ID Numbers: TP-015 & TP-038
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases