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

Tracking Information
First Submitted Date  ICMJE June 5, 2007
First Posted Date  ICMJE June 7, 2007
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
To provide confirmation that renal denervation is safe and feasible. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
To provide confirmation that renal denervation is safe and feasible.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2010)
Evidence of renal denervation; indication of physiologic response; assessment of device performance. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2007)
Evidence of renal denervation; indication of physiologic response; assessment of device performance.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation in Patients With Refractory Hypertension
Official Title  ICMJE Renal Denervation in Patients With Refractory Hypertension
Brief Summary To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Hypertension
Intervention  ICMJE Device: Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter
Study Arms  ICMJE Experimental: Denervation
Renal denervation using the Symplicty Catheter
Intervention: Device: Ardian Symplicity™ Catheter
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2010)
73
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483808
Other Study ID Numbers  ICMJE TP-015 & TP-038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Vascular
Study Sponsor  ICMJE Medtronic Vascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Vascular
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP