Renal Denervation in Patients With Refractory Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00483808
First received: June 5, 2007
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Hypertension
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00483808

Locations
Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Poland
John Paul II Hospital
Krakow, Poland
Sponsors and Collaborators
Medtronic Vascular
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Vascular
ClinicalTrials.gov 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:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014