Renal Denervation in Patients With Refractory Hypertension

This study has been completed.
Information provided by (Responsible Party):
Medtronic Vascular Identifier:
First received: June 5, 2007
Last updated: November 1, 2013
Last verified: November 2013

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

Condition Intervention Phase
Device: Ardian Symplicity™ Catheter
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Renal Denervation in Patients With Refractory Hypertension

Resource links provided by NLM:

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • To provide confirmation that renal denervation is safe and feasible. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evidence of renal denervation; indication of physiologic response; assessment of device performance. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: June 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denervation
Renal denervation using the Symplicty Catheter
Device: Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00483808

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
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
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Medtronic Vascular Identifier: NCT00483808     History of Changes
Other Study ID Numbers: TP-015 & TP-038
Study First Received: June 5, 2007
Last Updated: November 1, 2013
Health Authority: Australia: Department of Health and Aging Therapeutic Goods Administration

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on April 15, 2014