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

June 5, 2007
November 1, 2013
June 2007
May 2013   (final data collection date for primary outcome measure)
To provide confirmation that renal denervation is safe and feasible. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To provide confirmation that renal denervation is safe and feasible.
Complete list of historical versions of study NCT00483808 on ClinicalTrials.gov Archive Site
Evidence of renal denervation; indication of physiologic response; assessment of device performance. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Evidence of renal denervation; indication of physiologic response; assessment of device performance.
Not Provided
Not Provided
 
Renal Denervation in Patients With Refractory Hypertension
Renal Denervation in Patients With Refractory Hypertension

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

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Hypertension
Device: Ardian Symplicity™ Catheter
Renal denervation using the Symplicity Catheter
Experimental: Denervation
Renal denervation using the Symplicty Catheter
Intervention: Device: Ardian Symplicity™ Catheter

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Poland
 
NCT00483808
TP-015 & TP-038
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
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
Medtronic Vascular
November 2013

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